
[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31976-32002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14453]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a list of class II devices that the Agency has determined based on 
established factors to no longer require premarket notification to 
provide reasonable assurance of safety and effectiveness, subject to 
certain limitations. FDA is publishing this notice of that 
determination in accordance with procedures established by the 21st 
Century Cures Act. This notice represents FDA's final determination 
with respect to the list of class II devices proposed in a March 14, 
2017, Federal Register document. The exemptions in this notice will 
decrease regulatory burdens on the medical device industry and will 
eliminate private costs and expenditures required to comply with 
certain Federal regulations.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: 
Gregory.Bennett@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued 
a notice proposing to exempt a list of class II devices from the 
premarket notification requirements under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject 
to certain limitations. This notice was issued in accordance with the 
21st Century Cures Act (Pub. L. 114-255), which was signed into law on 
December 13, 2016. Section 3054 of that statute amended section 510(m) 
of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act 
provides that, within 90 days after enactment of the 21st Century Cures 
Act and at least once every 5 years thereafter, FDA must publish in the 
Federal Register a notice containing a list of each type of class II 
device that FDA determines no longer requires a report under section 
510(k) of the FD&C Act (generally referred to as a premarket 
notification or ``510(k)'') to provide reasonable assurance of safety 
and effectiveness. Within 210 days of enactment of the 21st Century 
Cures Act, FDA must publish in the Federal Register a list representing 
its final determination regarding the list of devices proposed in the 
March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that 
upon the date that this final list is published in the Federal 
Register, a 510(k) will no longer be required for the listed devices 
and the applicable classification regulation for these devices shall be 
deemed amended to incorporate such exemption. Interested persons were 
given until May 15, 2017, to comment on the proposed list of class II 
devices. After reviewing these comments and considering whether the 
proposed list should be modified, FDA is now identifying its final 
determination as to which of those devices are now exempt from 
premarket notification requirements, subject to certain limitations, as 
indicated in tables 1 to 3 of this notice.
    In a future action, FDA intends to amend the codified language for 
each listed device's classification regulation to reflect this final 
determination. Persons with pending 510(k) submissions for devices that 
are now exempt from premarket notification, subject to the limitations 
on exemptions, should withdraw their submissions.
    These exemptions will decrease regulatory burdens on the medical 
device industry and will eliminate private costs and expenditures 
required to comply with Federal regulation. Specifically, regulated 
industry will no longer have to invest time and resources in premarket 
notifications, including preparation of documents and data for 
submission to FDA, payment of user fees associated with 510(k) 
submissions, and responding to questions and requests for additional 
information from FDA during 510(k) review.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1).

[[Page 31977]]

III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this 
notice should be exempt from the premarket notification requirements 
found under section 510(k) of the FD&C Act. However, an exemption from 
the requirement of premarket notification does not mean that the device 
is exempt from any other statutory or regulatory requirements, unless 
such exemption is explicitly provided by order or regulation. FDA's 
determination that premarket notification is unnecessary to provide a 
reasonable assurance of safety and effectiveness for devices listed in 
this document is based, in part, on the assurance of safety and 
effectiveness that other regulatory controls, such as current good 
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the 
exemptions found in Title 21 of the Code of Federal Regulations (CFR) 
sections 862.9 to 892.9 (Sec. Sec.  862.9 to 892.9), when Agency 
assessment determines that the factors laid out in the Class II 510(k) 
Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all 
devices in a particular group, FDA may partially limit the exemption 
from premarket notification requirements to specific devices within a 
listed device type. In such situations where a partial exemption 
limitation has been identified, FDA has determined that premarket 
notification is necessary to provide a reasonable assurance of safety 
and effectiveness for these devices. Partial exemption limitations can 
be found in table 2 of this notice. FDA has assigned new product codes 
to the device types that are now exempt subject to the partial 
limitations in order to ensure that these devices can be separated from 
devices that do not fall within the partial exemption limitation under 
the existing product code (i.e., exempt and non-exempt devices within a 
device type will have distinct product codes). If table 2 indicates 
that a partial exemption limitation does apply to a device, then 
affected device manufacturers should review their registration and 
listing information to assess if they should list their device using 
the original classification product code, which requires premarket 
notification, or the new classification product code for the subset of 
that device type that is now 510(k) exempt (subject to the general 
limitations to the exemptions found in Sec. Sec.  862.9 to 892.9). In 
table 2, for example, FDA is listing the exemption of the tympanometer 
but limits the exemption to such devices that are in compliance with 
FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply 
with this partial exemption limitation and the corresponding general 
limitations in Sec.  874.9 are now exempt from the 510(k) requirements 
and should be identified under new product code ``PTP'' in subsequent 
registration and listing submissions. However, tympanometers not in 
compliance with each of these exemption limitations remain subject to 
the 510(k) requirements and will retain product code ``NAS.'' We 
recommend that device manufacturers document in their records any 
changes in the product code of their device with appropriate 
justification.

IV. List of Class II Devices

    In table 1, FDA is identifying the following list of class II 
devices that no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
      21 CFR section               Device type            Product code
------------------------------------------------------------------------
862.1020..................  Acid Phosphatase,          CJN
                             Nitrophenylphosphate.
862.1020..................  Acid Phosphatase, Thymol   CJR
                             Blue Monophosphate.
862.1020..................  Acid Phosphatase,          CJX
                             Disodium Phenylphosphate.
862.1020..................  Acid Phosphatase,          CKB
                             Naphthyl Phosphate.
862.1020..................  Acid Phosphatase,          CKE
                             Thymolphthale
                             Inmonophosphate.
862.1020..................  Acid Phosphatase, Beta     CKH
                             Glycerophosphate.
862.1020..................  Acid Phosphatase           JFH
                             (Prostatic), Tartrate
                             Inhibited.
862.1090..................  Radioassay, Angiotensin    KQN
                             Converting Enzyme.
862.1100..................  Vanillin Pyruvate, AST/    CIF
                             SGOT.
862.1100..................  Diazo, AST/SGOT..........  CIQ
862.1100..................  Hydrazone Colorimetry,     CIS
                             AST/SGOT.
862.1100..................  NADH Oxidation/NAD         CIT
                             Reduction, AST/SGOT.
862.1150..................  Calibrator, Primary......  JIS
862.1150..................  Calibrator, Secondary....  JIT
862.1150..................  Calibrator, Surrogate....  JIW
862.1150..................  Calibrator, Multi-Analyte  JIX
                             Mixture.
862.1345..................  Drink, Glucose Tolerance.  MRV
862.1350..................  Continuous Glucose         PJT
                             Monitor Secondary
                             Display.
862.1445..................  Chromatographic            CEX
                             Separation, Lactate
                             Dehydrogenase Isoenzymes.
862.1445..................  Electrophoretic, Lactate   CFE
                             Dehydrogenase Isoenzymes.
862.1445..................  Differential Rate Kinetic  JGF
                             Method, Lactate
                             Dehydrogenase Isoenzymes.
862.1509..................  System, Test, Urinary      LPT
                             Methylmalonic Acid.
862.1685..................  Radioimmunoassay,          CEE
                             Thyroxine-Binding
                             Globulin.
862.1700..................  Radioimmunoassay, Total    CDX
                             Thyroxine.
862.1700..................  Enzyme Immunoassay, Non-   KLI
                             Radiolabeled, Total
                             Thyroxine.
862.2265..................  High Throughput DNA        PFF
                             Sequence Analyzer.
862.2570..................  Instrumentation For        NSU
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Real Time Nucleic Acid     OOI
                             Amplification System.
862.2570..................  Mass Spectrometer For      OTA
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Micro Total Analysis       OUE
                             Instrument System.
862.2570..................  Complete Gene Expression   OVA
                             Profiling Accessory
                             Reagents.
862.2570..................  DNA Genetic Analyzer.....  PCA
862.2570..................  Data Acquisition Software  PQQ
862.3200..................  Calibrators, Drug Mixture  DKB
862.3200..................  Calibrators, Drug          DLJ
                             Specific.

[[Page 31978]]

 
862.3200..................  Calibrators, Ethyl         DNN
                             Alcohol.
864.5400..................  Fibrometer...............  GIE
864.5400..................  Timer, Coagulation.......  JBT
864.5425..................  Control, Plasma, Abnormal  GGC
864.5425..................  Plasma, Coagulation        GGN
                             Control.
864.5425..................  Plasma, Control, Normal..  GIZ
864.6550..................  Control, Fecal Occult      OSL
                             Blood.
864.6650..................  Study, Platelet Adhesive.  JBZ
864.7275..................  Test, Euglobulin Lysis...  JBO
864.7300..................  Fibrin Monomer             JBN
                             Paracoagulation.
864.7340..................  Fibrinogen Standard......  GFX
864.7340..................  Plasma, Fibrinogen         GIL
                             Control.
864.7375..................  Glutathione, Red-Cell....  GII
864.7375..................  Fluorescence, Visual       JMH
                             Observation (Qual.,
                             U.V.), Glutathione
                             Reductase.
864.7375..................  Assay, Glutathione         KQF
                             Reductase.
864.7415..................  Control, Hemoglobin,       JCM
                             Abnormal.
864.7455..................  Stain, Fetal Hemoglobin..  GHQ
864.7500..................  Acid Hematin.............  GGF
864.7720..................  Test, Prothrombin          GGQ
                             Consumption.
864.7735..................  Prothrombin-Proconvertin   JPF
                             and Thrombotest.
864.8150..................  Calibrator for Cell        KRX
                             Indices.
864.8165..................  Calibrator for Hemoglobin  KRZ
                             and Hematocrit
                             Measurement.
864.8175..................  Calibrator for Platelet    KRY
                             Counting.
864.8185..................  Calibrator for Red-Cell    KSA
                             and White-Cell Counting.
864.8625..................  Standards and Controls,    GFS
                             Hemoglobin, Normal and
                             Abnormal.
864.8625..................  Control, White-Cell......  GGL
864.8625..................  Control, Hemoglobin......  GGM
864.8625..................  Control, Platelet........  GJP
864.8625..................  Control, Red-Cell........  GJR
864.8625..................  Control, Hematocrit......  GLK
864.8625..................  Mixture, Control, White-   GLQ
                             Cell and Red-Cell
                             Indices.
864.8625..................  Control, Cell Counter,     JCN
                             Normal and Abnormal.
864.8625..................  Mixture, Hematology        JPK
                             Quality Control.
864.8625..................  Material, Quality          NRF
                             Control, Semen Analysis.
864.8625..................  Control Material, Blood    NRS
                             Circulating Epithelial
                             Cancer Cell.
864.9400..................  Solution, Stabilized       KSK
                             Enzyme.
866.3395..................  Norovirus Serological      OUC
                             Reagents.
866.5210..................  Immunochemical,            CHN
                             Ceruloplasmin.
866.5210..................  Ceruloplasmin, Rhodamine,  DCT
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, FITC,       DCY
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, Antigen,    DDB
                             Antiserum, Control.
866.5210..................  P-Phenyl-Enediamine/EDTA   JFQ
                             (Spectrophotometric),
                             Ceruloplasmin.
866.5210..................  Indirect Copper Assay,     JFR
                             Ceruloplasmin.
866.5470..................  Hemoglobin, Chain          DAM
                             Specific, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDT
                             Rhodamine, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDY
                             FITC, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DEB
                             Antigen, Antiserum,
                             Control.
866.5630..................  System, Test, Beta-2-      JZG
                             Microglobulin
                             Immunological.
866.5910..................  Quality Control Material,  NZB
                             Genetics, DNA.
868.1040..................  Algesimeter, Powered.....  BSI
868.1400..................  Legging, Compression, Non- LLK
                             Inflatable.
868.2500..................  Monitor, Oxygen,           KLK
                             Cutaneous, For Infant
                             Not Under Gas Anesthesia.
868.2500..................  Monitor, Oxygen,           LPP
                             Cutaneous, For Uses
                             Other Than For Infant
                             Not Under Gas Anesthesia.
868.2550..................  Pneumotachometer.........  JAX
868.5180..................  Bed, Rocking, Breathing    CCO
                             Assist.
868.6250..................  Compressor, Air, Portable  BTI
870.1390..................  Trocar...................  DRC
870.1875..................  Lung Sound Monitor.......  OCR
870.2675..................  Oscillometer.............  DRZ
870.4280..................  Filter, Prebypass,         KRJ
                             Cardiopulmonary Bypass.
870.4290..................  Adaptor, Stopcock,         DTL
                             Manifold, Fitting,
                             Cardiopulmonary Bypass.
870.4340..................  Monitor and/or Control,    DTW
                             Level Sensing,
                             Cardiopulmonary Bypass.
870.4420..................  Sucker, Cardiotomy         DTS
                             Return, Cardiopulmonary
                             Bypass.
870.4430..................  Suction Control,           DWD
                             Intracardiac,
                             Cardiopulmonary Bypass.
872.1720..................  Tester, Pulp.............  EAT
872.3260..................  External Cleaning          PME
                             Solution.
872.3300..................  Coating, Denture           EBE
                             Hydrophilic, Resin.
872.3540..................  Pad, Denture, Over The     EHR
                             Counter.
872.3540..................  Cushion, Denture, Over     EHS
                             The Counter.
872.3560..................  Reliner, Denture, Over     EBP
                             The Counter.
872.3590..................  Denture, Plastic, Tooth..  ELM

[[Page 31979]]

 
872.3600..................  Denture Preformed          EKO
                             (Partially Prefabricated
                             Denture).
872.3890..................  Splint, Endodontic         ELS
                             Stabilizing.
872.5550..................  Ring, Teething, Fluid-     KKO
                             Filled.
872.6770..................  Syringe, Cartridge.......  EJI
874.1120..................  Generator, Electronic      ETS
                             Noise (for Audiometric
                             Testing).
874.1325..................  Electroglottograph.......  KLX
874.3310..................  Calibrator, Hearing Aid/   ETW
                             Earphone and Analysis
                             Systems.
874.3320..................  Hearing Aid, Group and     EPF
                             Auditory Trainer.
874.3320..................  Device, Assistive          LZI
                             Listening.
874.3330..................  Hearing Aid, Master......  KHL
874.3430..................  Mold, Middle-Ear.........  ETC
874.3730..................  Device, Voice              MCK
                             Amplification.
876.1500..................  Light Source,              FCQ
                             Incandescent, Diagnostic.
876.1500..................  Light Source,              FCR
                             Photographic, Fiberoptic.
876.1500..................  Light Source, Fiberoptic,  FCW
                             Routine.
876.1500..................  Carrier, Sponge,           FGS
                             Endoscopic.
876.1500..................  Light Source, Endoscope,   GCT
                             Xenon Arc.
876.1500..................  Transformer, Endoscope...  GCW
876.1500..................  LED Light Source.........  NTN
876.1500..................  Endoscopic Guide Wire,     OCY
                             Gastroenterology-Urology.
876.4020..................  Light, Catheter,           FCS
                             Fiberoptic, Glass,
                             Ureteral.
876.4270..................  Rod, Colostomy...........  EZP
876.4400..................  Ligator, Hemorrhoidal....  FHN
876.4400..................  Ligator, Esophageal......  MND
876.4500..................  Lithotriptor, Biliary      LQC
                             Mechanical.
876.4770..................  Urethrotome..............  EZO
876.5010..................  Bag, Bile Collecting.....  EXF
876.5025..................  Vibrator for Climax        PIA
                             Control of Premature
                             Ejaculation.
876.5365..................  Dilator, Esophageal        EZM
                             (Metal Olive) Gastro-
                             Urology.
876.5365..................  Bougie, Esophageal, and    FAT
                             Gastrointestinal, Gastro-
                             Urology.
876.5365..................  Dilator, Esophageal......  KNQ
876.5520..................  Dilator, Urethral........  KOE
876.5665..................  Disinfectant, Subsystem,   NIH
                             Water Purification.
876.5820..................  Set, Dialyzer Holder.....  FKI
876.5895..................  Irrigator, Ostomy........  EXD
876.5980..................  Catheter, Retention,       FGD
                             Barium Enema With Bag.
876.5980..................  Gastrostomy Tube Holder..  PLI
878.4370..................  Drape, Surgical, ENT.....  ERY
878.4370..................  Drape, Pure Latex Sheet,   EYX
                             With Self-Retaining
                             Finger Cot.
878.4370..................  Drape, Urological,         EYY
                             Disposable.
878.4370..................  Pad, Kelly...............  FNW
878.4370..................  Drape, Patient,            HMT
                             Ophthalmic.
878.4370..................  Drape, Microscope,         HMW
                             Ophthalmic.
878.4370..................  Ring (Wound Protector),    KGW
                             Drape Retention,
                             Internal.
878.4580..................  Lamp, Operating-Room.....  FQP
878.4580..................  Light, Surgical,           FSQ
                             Instrument.
878.4580..................  Light, Surgical, Floor     FSS
                             Standing.
878.4580..................  Light, Surgical,           FSW
                             Endoscopic.
878.4580..................  Light, Surgical,           FSX
                             Connector.
878.4580..................  Light, Surgical, Ceiling   FSY
                             Mounted.
878.4580..................  Light, Surgical, Carrier.  FSZ
878.4580..................  Light, Surgical,           FTA
                             Accessories.
878.4580..................  Lamp, Surgical...........  FTD
878.4580..................  Illuminator, Remote......  FTG
878.4580..................  Lamp, Surgical,            GBC
                             Incandescent.
878.5070..................  Apparatus, Air Handling,   FZG
                             Bench.
878.5070..................  Apparatus, Air Handling,   FZH
                             Room.
878.5070..................  Apparatus, Air Handling,   FZI
                             Enclosure.
880.5580..................  Locator, Acupuncture       BWJ
                             Point.
880.5580..................  Needle, Acupuncture,       MQX
                             Single Use.
880.5780..................  Stocking, Medical Support  DWL
                             (to Prevent Pooling of
                             Blood in Legs).
882.1020..................  Analyzer, Rigidity.......  GZM
882.1540..................  Device, Galvanic Skin      GZO
                             Response Measurement.
882.1560..................  Device, Skin Potential     HCJ
                             Measurement.
882.1855..................  Encephalogram Telemetry    GYE
                             System.
882.5895..................  Vibratory Counter-         OVP
                             Stimulation.
884.2990..................  Sheet, Recording, Breast   NHM
                             Examination.
884.3200..................  Drain, Cervical..........  HFL
884.4400..................  Forceps, Obstetrical.....  HDA
884.4530..................  Clamp, Umbilical.........  HFW
884.4530..................  Speculum, Vaginal,         HIB
                             Nonmetal.

[[Page 31980]]

 
884.4530..................  Speculum, Vaginal,         HIC
                             Nonmetal, Fiberoptic.
884.4530..................  Clamp and Cutter,          NBZ
                             Umbilical.
884.4900..................  Table, Obstetrical, AC-    HDD
                             Powered (and
                             Accessories).
884.4900..................  Table, Obstetrical,        HHP
                             Manual (and Accessories).
884.4900..................  Table, Obstetric (and      KNC
                             Accessories).
884.5200..................  Hemorrhoid Prevention      OOA
                             Pressure Wedge.
884.5390..................  Heater, Perineal, Direct   HGZ
                             Contact.
884.5390..................  Heater, Perineal,          HHA
                             Radiant, Non-Contact.
884.5390..................  Heater, Perineal.........  KND
884.5400..................  Cup, Menstrual...........  HHE
884.5425..................  Pad, Menstrual, Scented..  HHL
884.6150..................  Micromanipulators and      MQJ
                             Microinjectors, Assisted
                             Reproduction.
886.1120..................  Photorefractor...........  MMF
886.1120..................  Camera, Ophthalmic,        PJZ
                             General-Use.
886.1250..................  Euthyscope, AC-Powered...  HMK
886.1570..................  Ophthalmoscope, AC-        HLI
                             Powered.
886.1570..................  Ophthalmoscope, Battery-   HLJ
                             Powered.
886.1570..................  Ophthalmoscopes,           MSG
                             Replacement Batteries,
                             Hand-Held.
886.1780..................  Retinoscope, AC-Powered..  HKL
886.1945..................  Transilluminator, AC-      HJM
                             Powered.
886.4150..................  Tubing, Replacement,       MSR
                             Phacofragmentation Unit.
886.4250..................  Unit, Electrolysis, AC-    HRO
                             Powered, Ophthalmic.
886.4335..................  Headlight, Fiberoptic      FCT
                             Focusing.
886.4335..................  Light, Headband, Surgical  FSR
886.4335..................  Headlamp, Operating, AC-   HPQ
                             Powered.
886.4400..................  Locator, Metal,            HPM
                             Electronic.
886.4440..................  Magnet, AC-Powered.......  HPO
886.4790..................  Sponge, Ophthalmic.......  HOZ
886.4790..................  Eye Tray.................  OJK
888.1240..................  Dynamometer, AC-Powered..  LBB
888.4580..................  Instrument, Surgical,      JDX
                             Sonic and Accessory/
                             Attachment.
888.4580..................  System, Cement Removal     LZV
                             Extraction.
890.1450..................  Hammer, Reflex, Powered..  IKO
890.5100..................  Bath, Hydro-Massage......  ILJ
890.5100..................  Bath, Sitz, Powered......  ILM
890.5110..................  Bath, Paraffin...........  IMC
890.5250..................  Cabinet, Moist Steam.....  IMB
890.5360..................  Exerciser, Measuring.....  ISD
890.5500..................  Lamp, Infrared,            ILY
                             Therapeutic Heating.
890.5575..................  Device, Warning,           IRN
                             Overload, External Limb,
                             Powered.
892.1000..................  MRI Disposable Kit.......  OIM
892.1560..................  Biopsy Needle Guide Kit..  OIJ
892.1610..................  Aperature, Radiographic..  IZS
892.1610..................  Cone, Radiographic.......  IZT
892.1610..................  Collimator, Automatic,     IZW
                             Radiographic.
892.1610..................  Collimator, Manual,        IZX
                             Radiographic.
892.1610..................  Device, Beam Limiting, X-  KPW
                             Ray, Diagnostic.
892.1650..................  Arthrogram Tray..........  OII
892.1650..................  Radiology Dental Tray....  OIK
892.1670..................  Device, Spot-Film........  IXL
892.1680..................  Radiographic Contrast      OIO
                             Tray.
892.1680..................  Radiology Diagnostic Kit.  OIP
892.1730..................  Discography Kit..........  OIL
892.1820..................  Chair,                     HBK
                             Pneumocephalographic.
892.1850..................  Cassette, Radiographic     IXA
                             Film.
892.1860..................  Changer, Radiographic      KPX
                             Film/Cassette.
892.1870..................  Programmer, Changer, Film/ IZP
                             Cassette, Radiographic.
892.1900..................  Controller, Temperature,   EGT
                             Radiographic.
892.1900..................  Dryer, Film, Radiographic  EGW
892.1900..................  Processor, Radiographic-   EGY
                             Film, Automatic, Dental.
892.1900..................  Processor, Radiographic-   IXW
                             Film, Automatic.
892.1900..................  Processor, Cine Film.....  IXX
892.2030..................  Digitizer, Image,          LMA
                             Radiological.
892.2030..................  Digitizer, Images,         NFH
                             Ophthalmic.
892.2040..................  Camera, Multi Format,      LMC
                             Radiological.
892.2040..................  Device, Hardcopy, Images,  NFI
                             Ophthalmic.
892.5730..................  Prostate Seeding Kit.....  OIN
------------------------------------------------------------------------


[[Page 31981]]

    In table 2, FDA is identifying a list of class II devices that no 
longer require premarket notification under section 510(k) of the FD&C 
Act, subject to the general limitations to the exemptions found in 
Sec. Sec.  862.9 to 892.9, as well as the indicated partial exemption 
limitations. Devices listed in table 2 are now exempt, but only if they 
are in concurrent compliance with both the partial exemption limitation 
specified in table 2 and its corresponding general limitation found in 
the .9 section of Parts 862 to 892 of Title 21 of the CFR.

                                            Table 2--Class II Devices
----------------------------------------------------------------------------------------------------------------
                                                      Exempt product    Former  product      Partial exemption
         21 CFR Section             Device type            code        code (non-exempt)        limitation
----------------------------------------------------------------------------------------------------------------
862.3100.......................  Enzyme             PUX..............  DKZ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Radioimmunoassay,  PUX..............  DJP..............  Exemption is limited
                                  Amphetamine.                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Thin Layer         PUX..............  DIT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Gas                PUX..............  DOD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Liquid             PUX..............  DNI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Free Radical       PUX..............  DJL..............  Exemption is limited
                                  Assay,                                                   to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Enzyme             PUY..............  DIS..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31982]]

 
862.3150.......................  Radioimmunoassay,  PUY..............  DKN..............  Exemption is limited
                                  Barbiturate.                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Thin Layer         PUY..............  DKX..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Mercury            PUY..............  DJN..............  Exemption is limited
                                  Dithiazone,                                              to test systems
                                  Colorimetry,                                             intended for
                                  Barbiturate.                                             employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Hemagglutination   PUY..............  DLX..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Gas Liquid         PUY..............  DMF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  High Pressure      PUY..............  KZY..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Barbiturate.                                             employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Enzyme             PUZ..............  JXM..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  High Pressure      PUZ..............  LAA..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Benzodiazepine.                                          employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31983]]

 
862.3170.......................  Test,              PUZ..............  NFV..............  Exemption is limited
                                  Benzodiazepine,                                          to test systems
                                  Over The Counter.                                        intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Gas                PUZ..............  KZZ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Thin Layer         PUZ..............  LAB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Enzyme             PVA..............  DIO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine and                                              intended for
                                  Cocaine                                                  employment and
                                  Metabolites.                                             insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Radioimmunoassay,  PVA..............  KLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolite.                                              intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Enzyme             PVA..............  JXO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Hemagglutination,  PVA..............  DLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolites                                              intended for
                                  (Benzoylecgonine                                         employment and
                                  ).                                                       insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Thin Layer         PVA..............  DMN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31984]]

 
862.3250.......................  Free Radical       PVA..............  DIR..............  Exemption is limited
                                  Assay, Cocaine.                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Gas                PVA..............  DIN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Thin Layer         PVA..............  DOM..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzoylecgonine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  High Pressure      PVA..............  LAC..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Cocaine and                                              employment and
                                  Cocaine                                                  insurance testing
                                  Metabolites.                                             that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  High Pressure      PVB..............  LAE..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Codeine.                                                 employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  Thin Layer         PVB..............  DLD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  Gas                PVB..............  LAD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3580.......................  Radioimmunoassay,  PVC..............  DLB..............  Exemption is limited
                                  LSD (125-I).                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31985]]

 
862.3580.......................  Free Radical       PVC..............  DOL..............  Exemption is limited
                                  Assay, LSD.                                              to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Gas                PVD..............  LAF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Thin Layer         PVD..............  DJC..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  High Pressure      PVD..............  LAG..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Methamphetamine.                                         employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Test,              PVD..............  NGG..............  Exemption is limited
                                  Methamphetamine,                                         to test systems
                                  Over The Counter.                                        intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Enzyme             PVE..............  DJR..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Hemagglutination   PVE..............  DIW..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Gas                PVE..............  DMB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31986]]

 
862.3620.......................  Thin Layer         PVE..............  DKR..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Liquid             PVE..............  DNT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Free Radical       PVE..............  DPP..............  Exemption is limited
                                  Assay, Methadone.                                        to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3630.......................  Radioimmunoassay,  PVF..............  KXS..............  Exemption is limited
                                  Methaqualone.                                            to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Thin Layer         PVG..............  DNK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DOE..............  Exemption is limited
                                  Morphine (123-                                           to test systems
                                  I), Goat                                                 intended for
                                  Antibody                                                 employment and
                                  Ammonium Sulfate                                         insurance testing
                                  Sep..                                                    that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Fluorometry,       PVG..............  DJJ..............  Exemption is limited
                                  Morphine.                                                to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Liquid             PVG..............  DPK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31987]]

 
862.3640.......................  Gas                PVG..............  DMY..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Hemagglutination   PVG..............  DLR..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Free Radical       PVG..............  DOK..............  Exemption is limited
                                  Assay, Morphine.                                         to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DIQ..............  Exemption is limited
                                  Morphine (3-H),                                          to test systems
                                  Goat Antibody                                            intended for
                                  Ammonium Sulfate                                         employment and
                                  Sep..                                                    insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DNA..............  Exemption is limited
                                  Morphine-                                                to test systems
                                  Barbiturate (125-                                        intended for
                                  I), Goat                                                 employment and
                                  Antibody.                                                insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Enzyme             PVH..............  DJG..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Gas                PVH..............  DJF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Hemagglutination,  PVH..............  DLT..............  Exemption is limited
                                  Opiates.                                                 to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31988]]

 
862.3650.......................  Thin Layer         PVH..............  LAI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Free Radical       PVH..............  DKT..............  Exemption is limited
                                  Assay, Opiates.                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  High Pressure      PVH..............  LAH..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Opiates.                                                 employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Enzyme             PVI..............  JXN..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Thin Layer         PVI..............  DPN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Gas                PVI..............  LAJ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  High Pressure      PVI..............  LAK..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Propoxyphene.                                            employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3870.......................  Enzyme             PVJ..............  LDJ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cannabinoids.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31989]]

 
862.3870.......................  Reagents, Test,    PVJ..............  DKE..............  Exemption is limited
                                  Tetrahydrocannab                                         to test systems
                                  inol.                                                    intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3870.......................  Radioimmunoassay,  PVJ..............  LAT..............  Exemption is limited
                                  Cannabinoid(S).                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  High Pressure      PVK..............  LFI..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Tricyclic                                                employment and
                                  Antidepressant                                           insurance testing
                                  Drugs.                                                   that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  U.V.               PVK..............  LFH..............  Exemption is limited
                                  Spectrometry,                                            to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  Thin Layer         PVK..............  MLK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
866.5750.......................  System, Test,      PUW..............  DHB..............  Exemption is limited
                                  Radioallergosorb                                         to devices classified
                                  ent (RAST)                                               under 21 CFR 866.5750
                                  Immunological.                                           that are intended to
                                                                                           detect any of the
                                                                                           allergens included in
                                                                                           table 3 of this
                                                                                           document.
868.2385.......................  Analyzer,          PUG..............  MRQ..............  Exemption is limited
                                  Nitrogen Dioxide.                                        to standalone
                                                                                           nitrogen dioxide
                                                                                           analyzers and not
                                                                                           those that are
                                                                                           components of nitric
                                                                                           oxide delivery
                                                                                           systems intended to
                                                                                           monitor nitrogen
                                                                                           dioxide levels during
                                                                                           inhaled nitric oxide
                                                                                           therapy.
870.1330.......................  Wire, Guide,       PTL..............  DQX..............  Exemption is limited
                                  Catheter.                                                to accessory torque
                                                                                           devices that are
                                                                                           manually operated,
                                                                                           non-patient
                                                                                           contacting, and
                                                                                           intended to
                                                                                           manipulate non-
                                                                                           cerebral vascular
                                                                                           guide wires.
870.1650.......................  Syringe, Balloon   PTM..............  MAV..............  Exemption is limited
                                  Inflation.                                               to non-patient
                                                                                           contacting balloon
                                                                                           inflation syringes
                                                                                           intended only to
                                                                                           inflate/deflate
                                                                                           balloon catheters and
                                                                                           monitor pressure
                                                                                           within the balloon.
870.2770.......................  Analyzer, Body     PUH..............  MNW..............  Exemption is limited
                                  Composition.                                             to body composition
                                                                                           analyzers which are
                                                                                           not intended to
                                                                                           diagnose or treat any
                                                                                           medical condition.
870.4400.......................  Reservoir, Blood,  PTN..............  DTN..............  Exemption is limited
                                  Cardiopulmonary                                          to cardiopulmonary
                                  Bypass.                                                  bypass blood
                                                                                           reservoirs that do
                                                                                           not contain defoamers
                                                                                           or blood filters.
874.1090.......................  Tester, Auditory   PTO..............  ETY..............  Exemption is limited
                                  Impedance.                                               to auditory impedance
                                                                                           testers that are in
                                                                                           compliance with FDA-
                                                                                           recognized consensus
                                                                                           standard ANSI S3.39.
874.1090.......................  Tympanometer.....  PTP..............  NAS..............  Exemption is limited
                                                                                           to tympanometers that
                                                                                           are in compliance
                                                                                           with FDA-recognized
                                                                                           consensus standard
                                                                                           ANSI S3.39.
876.1500.......................  Endoscopic         PTQ..............  FCC..............  Exemption is limited
                                  Magnetic                                                 to endoscopic
                                  Retriever.                                               magnetic retrievers
                                                                                           intended for single
                                                                                           use.
876.1500.......................  Scissors For       PTR..............  KGD..............  Exemption is limited
                                  Cystoscope.                                              to sterile scissors
                                                                                           for cystoscope
                                                                                           intended for single
                                                                                           use.

[[Page 31990]]

 
876.1500.......................  Endoscopic         PTS..............  OCZ..............  Exemption is limited
                                  Grasping/Cutting                                         to disposable, non-
                                  Instrument, Non-                                         powered endoscopic
                                  Powered.                                                 grasping/cutting
                                                                                           instruments intended
                                                                                           for single use.
876.5010.......................  Catheter,          PTT..............  GCA..............  Exemption is limited
                                  Biliary,                                                 to surgical biliary
                                  Surgical.                                                catheters that do not
                                                                                           include a balloon
                                                                                           component.
876.5630.......................  Catheter,          PTU..............  FJS..............  Exemption is limited
                                  Peritoneal, Long-                                        to non-patient
                                  Term Indwelling.                                         contacting catheter
                                                                                           finger grips intended
                                                                                           for single use.
876.5630.......................  Catheter,          PTV..............  FKO..............  Exemption is limited
                                  Peritoneal                                               to non-patient
                                  Dialysis, Single                                         contacting catheter
                                  Use.                                                     finger grips intended
                                                                                           for single use.
876.5630.......................  System,            PTW..............  FKX..............  Exemption is limited
                                  Peritoneal,                                              to continuous
                                  Automatic                                                ambulatory peritoneal
                                  Delivery.                                                dialysis (CAPD) belts
                                                                                           and catheter stands
                                                                                           that do not include
                                                                                           weigh scales.
878.4370.......................  Drape, Surgical..  PUI..............  KKX..............  Exemption is limited
                                                                                           to surgical drapes
                                                                                           that do not include
                                                                                           an antimicrobial
                                                                                           agent.
878.4495.......................  Suture,            PTX..............  GAQ..............  Exemption is limited
                                  Nonabsorbable,                                           to steel monofilament
                                  Steel,                                                   sutures that are
                                  Monofilament And                                         uncoated and do not
                                  Multifilament,                                           incorporate barbs.
                                  Sterile.
882.1470.......................  Computerized       PTY..............  PKQ..............  Exemption is limited
                                  Cognitive                                                to computerized
                                  Assessment Aid.                                          cognitive assessment
                                                                                           aids that are not
                                                                                           intended for
                                                                                           diagnostic assessment
                                                                                           of specific diseases
                                                                                           or conditions and
                                                                                           rely on inputs from
                                                                                           visual cues, auditory
                                                                                           cues, and/or
                                                                                           functional use of the
                                                                                           hand.
884.1630.......................  Colposcope (and    PTZ..............  HEX..............  Exemption is limited
                                  Colpomicroscope).                                        to standard
                                                                                           colposcopes (and
                                                                                           colpomicroscopes)
                                                                                           that use only a white
                                                                                           light source, do not
                                                                                           use filters other
                                                                                           than a green filter,
                                                                                           do not include image
                                                                                           analysis software,
                                                                                           and are not
                                                                                           smartphone-based.
884.4530.......................  Tenaculum,         PUA..............  HDC..............  Exemption is limited
                                  Uterine.                                                 to sterile uterine
                                                                                           tenaculum devices
                                                                                           that do not use
                                                                                           suction and are
                                                                                           intended for single
                                                                                           use.
884.6120.......................  Accessory,         PUB..............  MQG..............  Exemption is limited
                                  Assisted                                                 to simple embryo
                                  Reproduction.                                            incubators with
                                                                                           temperature, gas, and
                                                                                           humidity control
                                                                                           only; syringe pumps;
                                                                                           collection tube
                                                                                           warmers; dish/plate/
                                                                                           microscope stage
                                                                                           warmers; and
                                                                                           controlled-rate
                                                                                           cryopreservation
                                                                                           freezers.
884.6130.......................  Microtools,        PUC..............  MQH..............  Exemption is limited
                                  Assisted                                                 to assisted
                                  Reproduction                                             reproduction
                                  (Pipettes).                                              microtools (pipettes)
                                                                                           manufactured from
                                                                                           glass.
884.6160.......................  Labware, Assisted  PUD..............  MQK..............  Exemption is limited
                                  Reproduction.                                            to dishes and plates
                                                                                           that are intended for
                                                                                           general assisted
                                                                                           reproduction
                                                                                           technology
                                                                                           procedures.
886.1850.......................  Biomicroscope,     PUE..............  HJO..............  Exemption is limited
                                  Slit-Lamp, AC-                                           to slit-lamp, AC-
                                  Powered.                                                 powered
                                                                                           biomicroscopes
                                                                                           intended only for the
                                                                                           visual examination of
                                                                                           the anterior segment
                                                                                           of the eye, are
                                                                                           classified as Group 1
                                                                                           per FDA-recognized
                                                                                           consensus standard
                                                                                           ANSI Z80.36, do not
                                                                                           provide any
                                                                                           quantitative output,
                                                                                           and are not intended
                                                                                           for screening or
                                                                                           automated diagnostic
                                                                                           indications.
886.3320.......................  Ocular Peg.......  PUF..............  MQU..............  Exemption is limited
                                                                                           to ocular pegs
                                                                                           supplied sterile.
----------------------------------------------------------------------------------------------------------------

    In table 2, FDA included devices classified under Sec.  866.5750 
(Radioallergosorbent (RAST) immunological test system). FDA does not 
believe that all devices classified under this regulation meet the 
exemption criteria from premarket notification requirements. The 
devices listed in table 3 are also classified under Sec.  866.5750, but 
this subset no longer requires premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec.  866.9. While the non-exempt devices 
classified under Sec.  866.5750 will retain product code ``DHB'', these 
devices listed in table 3 are reassigned product code ``PUW.''

                        Table 3--Class II Devices
[Sec.   866.5750--Radioallergosorbent (RAST) Immunological Test Systems]
------------------------------------------------------------------------
                                                   Source (taxonomical
     Allergen code          Allergen product              name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1....................  Sweet vernal grass.....  Anthoxanthum odoratum.
g3....................  Cocksfoot grass,         Dactylis glomerata.
                         Orchard grass.
g4....................  Meadow fescue..........  Festuca elatior.
g5....................  Rye-grass (perennial     Lolium perenne.
                         rye grass).
g7....................  Common reed (common      Phragmites communis.
                         reed grass).
g8....................  Meadow grass, Kentucky   Poa pratensis.
                         blue (June grass).

[[Page 31991]]

 
g9....................  Redtop, Bentgrass......  Agrostis stolonifera
                                                 Agrostis gigantea
                                                  (Agrostis alba).
g11...................  Brome grass............  Bromus inermis.
g12...................  Cultivated rye           Secale cereale.
                         (cultivated rye grass).
g13...................  Velvet grass...........  Holcus lanatus.
g14...................  Cultivated oat           Avena sativa.
                         (cultivated oat grass).
g15...................  Cultivated wheat         Triticum aestivum
                         (cultivated wheat       (Triticum spp.).
                         grass).
g16...................  Meadow foxtail (meadow   Alopecurus pratensis.
                         foxtail grass).
g17...................  Bahia grass............  Paspalum notatum.
g24...................  Wheat grass, Western...  Agropyron smithii
                                                 (Elymus smithii).
g30...................  Bluegrass, annual......  Poa annua.
g70...................  Wild rye grass.........  Elymus triticoides
                                                 Elymus condensatus.
g71...................  Canary grass...........  Phalaris arundinacea.
g201..................  Barley, cultivated.....  Hordeum vulgare.
g202..................  Maize, corn (cultivated  Zea mays.
                         corn).
g203..................  Salt grass.............  Distichlis spicata.
g204..................  False oat-grass........  Arrhenatherum elatius.
g216..................  Cyn d 1................  Cynodon dactylon.
g701..................  Phl p 1.0102, Phl p      Phleum pratense.
                         5.0101.
g702..................  Phl p 7.0101...........  Phleum pratense.
g703..................  Phl p 12.0101..........  Phleum pratense.
------------------------------------------------------------------------
                              Weed Pollens
------------------------------------------------------------------------
w2....................  Western ragweed........  Ambrosia psilostachya.
w4....................  False ragweed..........  Ambrosia acanthicarpa
                                                 (Franseria
                                                  acanthicarpa).
w5....................  Wormwood...............  Artemisia absinthium
                                                 Artemisia annua.
w6....................  Mugwort................  Artemisia vulgaris.
w7....................  Marguerite, ox-eye       Chrysanthemum
                         daisy.                   leucanthemum.
w8....................  Dandelion..............  Taraxacum vulgare
                                                 Taraxacum officinale.
w9....................  Plantain (English),      Plantago lanceolata.
                         Ribwort.
w10...................  Goosefoot, lamb's        Chenopodium album.
                         quarters.
w11...................  Saltwort (prickly),      Salsola kali
                         Russian thistle.        (Salsola pestifer).
w12...................  Goldenrod..............  Solidago virgaurea
                                                 (Solidago spp.)
w13...................  Cocklebur, common......  Xanthium commune.
w14...................  Common pigweed (rough    Amaranthus retroflexus.
                         pigweed).
w15...................  Scale, Lenscale........  Atriplex lentiformis.
w16...................  Rough marsh elder......  Iva ciliate
                                                 Iva annua.
w17...................  Firebush (Kochia)......  Kochia scoparia.
w18...................  Sheep sorrel...........  Rumex acetosella.
w19...................  Wall pellitory.........  Parietaria officinalis.
w20...................  Nettle (Common stinging  Urtica dioica.
                         nettle).
w21...................  Wall pellitory.........  Parietaria judaica.
w22...................  Japanese hop (careless   Humulus japonicas
                         weed).                  (Humulus scandens).
w23...................  Yellow dock, Yellow      Rumex crispus.
                         dockweed.
w24...................  Spiny pigweed..........  Amaranthus spinosus.
w27...................  Carnation..............  Dianthus spp.
w28...................  Rose...................  Rosa rugosa.
w33...................  Clover.................  Trifolium pratense.
w35...................  Mexican tea............  Chenopodium
                                                  ambrosioides.
w36...................  Rabbit bush............  Ambrosia deltoidea
                                                 (Franseria deltoides).
w37...................  Salt bush, annual......  Atriplex wrightii.
w39...................  Water hemp, Western....  Amaranthus rudis
                                                 (Acnida tamariscina).
w41...................  Burrobrush.............  Hymenoclea salsola.
w42...................  Poverty weed...........
w43...................  Common sagebrush.......  Artemisia tridentata.
w45...................  Alfalfa................  Medicago sativa.
w46...................  Dog fennel.............  Eupatorium
                                                  capillifolium.

[[Page 31992]]

 
w53...................  Geranium...............  Geranium spp.
w67...................  Groundsel bush.........  Baccharis halimifolia.
w69...................  Iodine bush............  Allenrolfea
                                                  occidentalis.
w70...................  Ragweed, slender.......  Ambrosia confertiflora.
w75...................  Wing scale (wingscale).  Atriplex canescens.
w82...................  Careless weed..........  Amaranthus palmeri
                                                 Amaranthus hybridus.
w90...................  Japanese hop...........  Humulus japonicas
                                                 (Humulus scandens).
w203..................  Rape (rape pollen).....  Brassica napus.
w204..................  Sunflower..............  Helianthus annuus.
w206..................  Camomile...............  Matricaria chamomilla.
w207..................  Lupin..................  Lupinus spp.
w210..................  Sugar-beet.............  Beta vulgaris.
w211..................  Par j 2.0101...........  Parietaria judaica.
w231..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort).
w232..................  Sal k 1................  Salsola kali.
w233..................  Art v 3................  Artemisa vulgaris (LTP,
                                                  Mugwort).
w234..................  Pla l 1................  Plantago lanceolata.
w235..................  Che a 1.0101...........  Chenopodium album.
w236..................  Mer a 1.0101...........  Mercurialis annua.
a753..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort weed).
------------------------------------------------------------------------
                              Tree Pollens
------------------------------------------------------------------------
t1....................  Box-elder (Maple)......  Acer negundo.
                                                 Acer saccharum.
t2....................  Gray alder, speckled     Alnus incana.
                         alder (alder).
t4....................  Hazel, hazelnut........  Corylus avellana.
                                                 Corylus americana.
t5....................  American beech (beech).  Fagus grandifolia.
                                                 (Fagus americana).
t6....................  Mountain juniper,        Juniperus ashei
                         Mountain cedar.         (Juniperus sabinoides).
t8....................  Elm....................  Ulmus americana.
t9....................  Olive..................  Olea europaea.
t10...................  Walnut.................  Juglans californica
                                                 Juglans nigra.
t11...................  Maple leaf sycamore,     Platanus acerifolia.
                         London plane, Plane
                         tree.
t61...................  Sycamore...............  Platanus occidentalis.
t12...................  Willow.................  Salix caprea
                                                 Salix nigra.
t14...................  Cottonwood (Eastern      Populus deltoides.
                         Cottonwood/Black
                         Cottonwood).
t15...................  White ash..............  Fraxinus americana.
t16...................  White pine.............  Pinus strobus.
t18...................  Eucalyptus, gum-tree...  Eucalyptus globulus.
                                                 (Eucalyptus spp.).
t19/t26...............  Acacia.................  Acacia longifolia
                                                  (Acacia spp.).
t20...................  Mesquite...............  Prosopis glandulosa/
                                                 Prosopis juliflora.
t21...................  Melaleuca, cajeput tree  Melaleuca quinquenervia
                                                  (Melaleuca
                                                  leucadendron).
t22...................  Pecan, hickory.........  Carya illinoinensis
                                                 (Carya pecan).
t23...................  Italian/Mediterranean/   Cupressus sempervirens.
                         funeral cypress.
t24...................  Japanese cypress.......  Chamaecyparis obtusa
                                                  (Chamaecyparis spp.).
t25...................  Ash....................  Fraxinus excelsior.
t27...................  Maple, red.............  Acer rubrum.
t29...................  Acacia.................  Acacia spp.
t30...................  Birch, white...........  Betula populifolia.
t32...................  Willow, black..........  Salix nigra.
t33...................  Ash, Arizona...........  Fraxinus velutina.
t35...................  Cedar, salt............  Tamarix gallica.
t37...................  Bald cypress (white      Taxodium distichum.
                         bald cypress).
t38...................  Elm, Chinese/Siberian..  Ulmus pumila.
t40...................  Hazelnut tree..........  Corylus americana.
t41...................  White hickory..........  Carya alba
                                                 (Carya tomentosa).
t42...................  Oak, red...............  Quercus rubra.
t43...................  Loblolly pine..........  Pinus taeda.
t44...................  Hackberry..............  Celtis occidentalis.

[[Page 31993]]

 
t45...................  Cedar elm..............  Ulmus crassifolia.
t47...................  Juniper, one seed......  Juniperus monosperma.
t48...................  Pine, lodgepole........  Pinus contorta.
t49...................  Pine, ponderosa........  Pinus ponderosa.
t50...................  Beech, European........  Fagus sylvatica.
t51...................  Tree of Heaven.........  Ailanthus altissima.
t52...................  Western white pine.....  Pinus monticola.
t54...................  Russian olive..........  Elaeagnus angustifolia.
t55...................  Scotch broom...........  Cytisus scoparius.
t56...................  Bayberry...............  Myrica cerifera.
t57...................  Red cedar..............  Juniperus virginiana.
t60...................  Western juniper........  Juniperus occidentalis.
t61...................  Sycamore...............  Platanus occidentalis.
t70...................  Mulberry (white          Morus alba.
                         mulberry).
t71...................  Red mulberry...........  Morus rubra.
t72...................  Queen palm.............  Arecastrum
                                                  romanzoffiamon.
t73...................  Australian pine........  Casuarina
                                                  equisetifolia.
t77...................  Oak mix (red, white,     Quercus spp.
                         black).
t80...................  Japanese cypress.......  Chamaecyparis obtusa.
t81...................  Japanese alder.........  Alnus japonica.
t83...................  Mango tree.............  Mangifera indica.
t90...................  Walnut, black..........  Juglans nigra.
t96...................  Poplar, white (poplar).  Populus alba.
t103/.................  Virginia live oak (live  Quercus virginiana.
t218..................   oak).
t105..................  Pepper tree............  Schinus molle.
t110..................  Orange tree............  Citrus sinensis.
t201..................  Spruce, Norway spruce..  Picea abies (Picea
                                                  excelsa).
t202..................  Alder, smooth..........  Alnus incana spp.
                                                  Rugosa
                                                 (Alnus rugosa).
t203..................  Horse chestnut.........  Aesculus hippocastanum.
t205..................  Elder..................  Sambucus nigra.
t206..................  Chestnut...............  Castanea sativa.
t207..................  Douglas fir............  Pseudotsuga menziesii
                                                  (Pseudotsuga
                                                  taxifolia).
t208..................  Linden.................  Tilia cordata.
t209..................  Horn beam..............  Carpinus betulus.
t210..................  Privet.................  Ligustrum vulgare.
t211..................  Sweet gum..............  Liquidambar
                                                  styraciflua.
t212..................  Cedar..................  Libocedrus decurrens.
t213..................  Pine...................  Pinus radiata.
t214..................  Date palm..............  Phoenix canariensis.
t215..................  Lilac..................  Syringa vulgaris.
t217..................  Pepper tree............  Schinus molle.
t217..................  Red alder..............  Alnus rubra.
t218..................  Virginia live oak......  Quercus virginiana.
t218..................  Bayberry (bayberry/      Myrica gale.
                         sweet gale).
t219..................  Palo verde.............  Cercidium floridum.
t219..................  Red cedar..............  Juniperus virginiana.
t220..................  Bet v 4................  Betula verrucosa
                                                  (Birch).
t221..................  Bet v 2.0101, Bet v 4..  Betula verrucosa
                                                  (Birch).
t222..................  Cypress (Arizona         Cupressus arizonica.
                         cypress).
t223..................  Oil palm...............  Elaeis guineensis.
t224..................  Ole e 1................  Olea europaea.
t225..................  Bet v 6................  Betula verrucosa
                                                  (Birch).
t226..................  Cup a 1................  Cupressus arizonica.
t227..................  Ole e 7................  Olea Europaea.
t228..................  Aspen, quaking.........  Populus tremuloides.
t229..................  Eastern hemlock........  Tsuga canadensis.
t230..................  Redwood (sequoia)......  Sequoia sempervirens.
t232..................  Pussy willow...........  Salix discolor.
t240..................  Ole e 9.0101...........  Olea Europaea.
t241..................  Pla a 1.0101...........  Platanus acerifolia.
t242..................  Pla a 2................  Platanus acerifolia.
t243..................  Pla a 3.0101...........  Platanus acerifolia.
t244..................  Cor a 1.0103...........  Corylus avellana.
t245..................  Aln g 1.0101...........  Alnus glutinosa.
t246..................  Cry j 1................  Cryptomeria japonica.
t280..................  Locust tree............  Robinia pseudoacacia.
t401..................  Brazilian peppertree...  Schinus
                                                  terebinthifolius.
t402..................  Mastic tree............  Pistacia lentiscus.

[[Page 31994]]

 
t404..................  Tree of heaven.........  Ailanthus altissima.
t406..................  Date palm..............  Phoenix dactylifera.
a482..................  Ole e 1................  Olea europaea (Olive
                                                  Oil).
------------------------------------------------------------------------
                                  Mites
------------------------------------------------------------------------
d207..................  Blo t 5.0101...........  Blomia tropicalis.
d208..................  Lep d 2.0101...........  Lepidoglyphus
                                                  destructor.
------------------------------------------------------------------------
                      Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1....................  Penicillium chrysogenum  Penicillium chrysogenum
                        (Penicillium notatum)..   (Penicillium notatum).
m2....................  Cladosporium herbarum    Cladosporium herbarum
                         (Hormodendrum).          (Hormodendrum).
m3....................  Aspergillus fumigatus..  Aspergillus fumigatus.
m4....................  Mucor racemosus........  Mucor racemosus.
m5....................  Candida albicans.......  Candida albicans.
m7....................  Botrytis cinerea.......  Botrytis cinerea.
m8....................  Drechslera halodes       Drechslera halodes
                         (Setomelanomma          (Setomelanomma
                         rostrata,                rostrata,
                         Helminthosporium         Helminthosporium
                         halodes,                 halodes).
                         Helminthosporium
                         interseminatum).
m9....................  Fusarium moniliforme     Fusarium moniliforme
                         (Fusarium               (Fusarium
                         proliferatum).           proliferatum).
m10...................  Stemphylium botryosum..  Stemphylium herbarum
                                                 (Stemphylium
                                                  botryosum).
m11...................  Rhizopus nigricans.....  Rhizopus nigricans.
m12...................  Aureobasidium pullulans  Aureobasidium
                                                  pullulans.
m13...................  Phoma betae............  Phoma betae.
m14...................  Epicoccum purpurascens.  Epicoccum purpurascens
                                                 (Epicoccum nigrum).
m15...................  Trichoderma viride.....  Trichoderma viride.
m16...................  Curvularia lunata......  Curvularia lunata
                                                 Curvularia specifera
                                                  (K923044).
m17...................  Cladosporium fulvum....  Cladosporium fulvum.
m18...................  Fusarium culmorum......  Fusarium culmorum.
m19...................  Aspergillus versicolor.  Aspergillus versicolor.
m20...................  Mucor mucedo...........  Mucor mucedo.
m21...................  Aspergillus clavatus...  Aspergillus clavatus.
m22...................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m23...................  Thermoactinomyces        Thermoactinomyces
                         vulgaris.                vulgaris.
m24...................  Stachybotrys atra......  Stachybotrys chartarum
                                                  (Stachybotrys atra).
m24...................  Paecilomyces spp.......  Paecilomyces spp.
m25...................  Aspergillus versicolor.  Aspergillus versicolor.
m25...................  Penicillium              Penicillium
                         brevicompactum.          brevicompactum.
m26...................  Cladosporium             Cladosporium
                         cladosporioides.         cladosporioides.
m26...................  Penicillium citrinum...  Penicillium citrinum.
m27...................  Penicillium spp........  Penicillium spp.
m29...................  Aspergillus repens.....  Aspergillus repens.
m30...................  Penicillium roqueforti.  Penicillium roqueforti.
m32...................  Cladosporium             Cladosporium
                         cladosporioides.         cladosporioides.
m34...................  Serpula lacrymans......  Serpula lacrymans.
m36...................  Aspergillus terreus....  Aspergillus terreus.
m37...................  Trichophyton             Trichophyton
                         mentagrophytes.          mentagrophytes.
m40...................  Aspergillus amstelodami  Aspergillus
                                                  amstelodami.
m43...................  Saccharomyces carlsberg  Saccharomyces
                                                  carlsbergensis.
m44...................  Saccharomyces            Saccharomyces
                         cerevisiae.              cerevisiae.
m45...................  Hormodendrum hordei....  Hormodendrum hordei.
m46...................  Bipolaris spicifera....  Bipolaris spicifera.
m47...................  Aspergillus nidulans...  Aspergillus nidulans.
m48...................  Aspergillus oryzae.....  Aspergillus oryzae.
m49...................  Fusarium oxysporum.....  Fusarium oxysporum.
m50...................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m51...................  Thermoactinomyces        Thermoactinomyces
                         vulgaris.                vulgaris.
m53...................  Microspora canis.......  Microsporum canis
                                                 (Microspora canis).
m54...................  Aspergillus flavus.....  Aspergillus flavus.
m63...................  Helminthosporium         Helminthosporium
                         intersemin.              intersemin.
m66...................  Mucor plumbeus.........  Mucor plumbeus.
m67...................  Mycogone...............  Mycogone perniciosa.
m68...................  Nigrospora oryzae......  Nigrospora oryzae.

[[Page 31995]]

 
m69...................  Rhodotorula............  Rhodotorula rubra
                                                 (Rhodotorula
                                                  mucilaginosa).
m70...................  Malassezia furfur        Malassezia furfur
                         (Pityrosporum           (Pityrosporum
                         orbiculare).             orbiculare).
m71...................  Spondylocladium........  Spondylocladium spp.
m72...................  Epidermophyton.........  Epidermophyton
                                                  floccosum.
m73...................  Epicoccum nigrum.......  Epicoccum purpurascens
                                                 (Epicoccum nigrum).
m80...................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin A (Sta a
                         SEA).
m80...................  Helminthosporium spp...  Helminthosporium spp.
m81...................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin B (Sta a
                         SEB).
m88...................  Stemphylium solani.....  Stemphylium solani.
m93...................  Gliocladium fimbriatum.  Gliocladium fimbriatum.
m94...................  Phycomyces               Phycomyces
                         blakesleeanus.           blakesleeanus.
m201..................  Tilletia tritici         Tilletia tritici
                         (Ustilago nuda,         (Ustilago nuda,
                         Ustilago tritici)        Ustilago tritici).
                         (Barley smut).
m202..................  Acremonium kiliense      Acremonium kiliense
                         (Cephalosporium          (Cephalosporium
                         acremonium).             acremonium).
m203..................  Trichosporon pullulans.  Trichosporon pullulans.
m204..................  Ulocladium chartarum...  Ulocladium chartarum.
m205..................  Trichophyton rubrum....  Trichophyton rubrum.
m207..................  Aspergillus niger......  Aspergillus niger.
m208..................  Chaetomium globosum....  Chaetomium globosum.
m209..................  Penicillium frequentans  Penicillium glabrum
                                                 (Penicillium
                                                  frequentans).
m209..................  Stachybotrys chartarum.  Stachybotrys chartarum
                                                  (Stachybotrys atra).
m210..................  Trichophyton             Trichophyton
                         mentagrophytes var.      mentagrophytes var.
                         goetzii.                 goetzii.
m211..................  Trichophyton             Trichophyton
                         mentagrophytes var.      mentagrophytes var.
                         interdigitale.           interdigitale.
m211..................  Oat smut...............  Ustilago avenae.
m212..................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m212..................  Geotrichum candidum....  Geotrichum candidum.
m213..................  Bermuda grass smut.....  Ustilago cynodontis.
m214..................  Johnson grass smut.....  Sphacelotheca cruenta.
m215..................  Corn smut..............  Ustilago maydis.
m218..................  Asp f 1.0101...........  Aspergillus fumigatus.
a3050.................  Asp r 1................  Aspergillus restrictus.
m219..................  Asp f 2................  Aspergillus fumigatus.
m220..................  Asp f 3.0101...........  Aspergillus fumigatus.
m221..................  Asp f 4................  Aspergillus fumigatus.
m222..................  Asp f 6.0101...........  Aspergillus fumigatus.
m223..................  Staphylococal            Staphylococus aureus.
                         enterotoxin C (Sta a
                         SEC).
m224..................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin D (Sta a
                         SED).
m226..................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin TSST (Sta
                         a TSST).
m227..................  Malassezia spp.          Malassezia spp.
                         (Pityrosporum spp.).     (Pityrosporum spp.).
m228..................  Aspergillus flavus.....
m229..................  Alt a 1.0101...........  Alternaria alternata
                                                  (Alternaria tenuis).
m230..................  Alt a 6.0101...........  Alternaria alternata
                                                  (Alternaria tenuis).
m231..................  Cla h 8.0101...........  Cladosporium herbarum
                                                  (Hormodendrum).
m300..................  Eurotium spp...........  Eurotium spp.
m304..................  Aspergillus oryzae.....  Aspergillus oryzae.
m305..................  Penicillium              Penicillium
                         brevicompactum.          brevicompactum.
m309..................  Aspergillus terreus....  Aspergillus terreus.
m310..................  Aspergillus nidulans...  Aspergillus nidulans.
m311..................  Aspergillus flavus.....  Aspergillus flavus.
m312..................  Aspergillus clavatus...  Aspergillus clavatus.
------------------------------------------------------------------------
                           Epidermal & Animal
------------------------------------------------------------------------
e6....................  Guinea pig epithelium..  Cavia porcellus.
e7....................  Pigeon droppings.......  Columba palumbus
                                                 Columba livia.
e25...................  Chicken serum..........  Gallus domesticus
                                                 (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e26...................  Parrot serum...........  Psittacoidea spp.
e62...................  Camel..................  Camelus dromedaries.
e70...................  Goose feathers.........  Anser anser.
e71...................  Mouse epithelium.......  Mus musculus
                                                 (Mus spp.).
e73...................  Rat epithelium.........  Rattus norvegicus.
e74...................  Rat urine proteins.....  Rattus norvegicus
                                                 Rattus rattus.

[[Page 31996]]

 
e75...................  Rat serum proteins.....  Rattus norvegicus
                                                 Rattus rattus.
e76...................  Mouse serum proteins...  Mus musculus
                                                 (Mus spp.).
e77...................  Budgerigar droppings...  Melopsittacus
                                                  undulatus.
e78...................  Budgerigar feathers....  Melopsittacus
                                                  undulatus.
e79...................  Budgerigar serum         Melopsittacus
                         proteins.                undulatus.
e80...................  Goat epithelium........  Capra hircus.
e81...................  Sheep epithelium.......  Ovis aries
                                                 (Ovis spp.).
e82...................  Rabbit epithelium......  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
e83...................  Swine epithelium.......  Sus scrofa
                                                 (Sus scrofa domesticus;
                                                  Sus spp.).
e84...................  Hamster epithelium.....  Cricetus cricetus,
                                                  Mesocricetus auratus,
                                                  and Phodopus sungorus.
e85...................  Chicken feathers.......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e86...................  Duck feathers..........  Anas platyrhynchos.
e87...................  Rat epithelium, serum    Rattus norvegicus
                         proteins, and urine     Rattus rattus.
                         proteins.
e88...................  Mouse epithelium, serum  Mus musculus (Mus
                         proteins, and urine      spp.).
                         proteins (mouse).
e89...................  Turkey feathers........  Meleagris gallopavo.
e90...................  Budgerigar serum         Melopsittacus
                         proteins, feathers,      undulatus.
                         and droppings.
e91...................  Pigeon serum proteins,   Streptopelia
                         feathers, and            roseogrisea
                         droppings.              Psittacidae spp.
e92...................  Parrot serum proteins,   Ara spp.
                         feathers, and
                         droppings.
e93...................  Pigeon serum proteins..  Streptopelia
                                                  roseogrisea.
e94...................  Fel d 1.0101...........  Felis domesticus.
a345..................  Fel d 1................  Felis domesticus.
e98...................  Parrot droppings.......  Psittacoidea spp.
e101..................  Can f 1.0101...........  Canis familiaris (Canis
                                                  domesticus).
a174..................  Can f 1................  Canis familiaris (Canis
                                                  domesticus).
e102..................  Can f 2.0101...........  Canis familiaris (Canis
                                                  domesticus).
e196..................  Parakeet feathers......  Nymphicus hollandicus.
e197..................  Parakeet droppings.....  Nymphicus hollandicus.
e198..................  Parakeet serum.........  Nymphicus hollandicus.
e199..................  Canary bird serum......  Serinus canarius.
e200..................  Canary bird droppings..  Serinus canarius.
e201..................  Canary bird feathers     Serinus canarius.
                         (Canary feathers).
e202..................  Reindeer epithelium....  Rangifer tarandus.
e203..................  Mink epithelium........  Mustela spp.
e204..................  Bos d 6................  Bos domesticus (Bos
                                                  taurus; Bos spp.).
e205..................  Horse, serum proteins..  Equus caballus (Equus
                                                  spp.).
e206..................  Rabbit, serum proteins.  Oryctolagus cuniculus
                                                  (Oryctolagus spp.).
e208..................  Chinchilla epithelium..  Chinchilla laniger.
e209..................  Gerbil epithelium......  Meriones unguiculatus.
e210..................  Fox epithelium.........  Vulpes vulpes.
e211..................  Rabbit, urine proteins.  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
e212..................  Swine, urine proteins..  Sus scrofa
                                                 (Sus scrofa domesticus;
                                                  Sus spp.).
e213..................  Parrot feathers........  Ara spp.
e214..................  Finch feathers.........  Lonchura domestica.
e215..................  Pigeon feathers........  Streptopelia
                                                  roseogrisea
                                                 (Streptopelia spp.)
                                                 Columbia spp.
e216..................  Deer epithelium........  Dama dama.
e217..................  Ferret epithelium......  Mustela putorius.
e218..................  Chicken droppings......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e219..................  Chicken, serum proteins  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e220..................  Fel d 2, Cat serum       Felis domesticus.
                         albumin.
e221..................  Can f 3................  Canis familiaris (Canis
                                                  domesticus)
                                                 (Dog serum albumin).
e222..................  Swine serum albumin      Sus scrofa (Sus scrofa
                         (Sus s PSA).             domesticus; Sus spp.).
e225..................  Lovebird feathers......  Psittacoidea agapomis.
e226..................  Can f 5.0101...........  Canis familiaris.
e227..................  Equ c 1.0101...........  Equus caballus.
e228..................  Fel d 4.0101...........  Felis domesticus.
e230..................  Equ c 3................  Equus caballus.

[[Page 31997]]

 
e231..................  Mus m 1................  Mus musculus.
------------------------------------------------------------------------
                                  Food
------------------------------------------------------------------------
f9....................  Rice...................  Oryza sativa.
f12...................  Pea (green pea)........  Pisum sativum.
f15...................  White bean.............  Phaseolus vulgaris.
f19...................  Cayenne pepper.........  Capsicum frutescens
                                                 (Capsicum annum).
f21...................  Sugar cane.............  Saccharum officinarum.
f22...................  Raspberry..............  Rubus idaeus.
f26...................  Pork...................  Sus scrofa (Sus scrofa
                                                  domesticus; Sus spp.).
f29...................  Watermelon.............  Citrullus lanatus
                                                 (Citrullus vulgaris).
f31...................  Carrot.................  Daucus carota.
f32...................  Oyster mushroom........  Pleurotus ostreatus.
f33...................  Orange.................  Citrus sinensis.
f35...................  Potato.................  Solanum tuberosum.
f43...................  Mother's milk..........  Homo sapiens.
f44...................  Strawberry.............  Fragaria vesca
                                                  (Fragaria spp.).
f45...................  Yeast, baker's.........  Saccharomyces
                                                  cerevisiae.
f46...................  Pepper, Red............  Capsicum annuum.
f47...................  Garlic.................  Allium sativum.
f48...................  Onion..................  Allium cepa.
f49...................  Apple..................  Malus x domestica
                                                 (Malus spp.).
f51...................  Bamboo shoot...........  Phyllostachys
                                                  pubescens.
f52...................  Cacao/chocolate........  Theobroma cacao.
f54...................  Sweet potato...........  Ipomoea batatas.
f55...................  Common millet..........  Panicum miliaceum.
f56...................  Foxtail millet.........  Setaria italica.
f57...................  Japanese millet........  Echinochloa crus-galli.
f58...................  Pacific squid..........  Todarodes pacificus.
f59...................  Octopus................  Octopus vulgaris
                                                  (Octopus spp.).
f63...................  Kefir..................  NA.
f67...................  Parmesan cheese........  NA.
f81...................  Cheese, cheddar type...  NA.
f82...................  Cheese, mold type......  NA.
f83...................  Chicken................  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
f86...................  Parsley................  Petroselinum crispum.
f87...................  Melon..................  Cucumis melo Cucumis
                                                  melo + Citrullus
                                                  lanatus.
f88...................  Mutton (lamb)..........  Ovis aries (Ovis spp.).
f90...................  Malt...................  Hordeum vulgare.
f92...................  Banana.................  Musa spp.
f93...................  Cacao..................  Theobroma cacao.
f94...................  Pear...................  Pyrus communis (Pyrus
                                                  spp.).
f97...................  Yam....................  Dioscorea spp.
                                                 Dioscorea opposita.
f97...................  Chamomile tea..........  Matricaria chamomilla.
f98...................  Gliadin................  Triticum aestivum
                                                  (Triticum spp.).
f102..................  Cantaloupe.............  Cucumis melo var.
                                                  cantalupensis.
f105..................  Chocolate..............  Theobroma cacao.
f109..................  Cottonseed.............  Gossypium hirsutum.
f110..................  Giant radish...........  Raphanus sativus.
f118..................  Zucchini...............  Cucurbita pepo.
f119..................  Radish.................  Raphanus sativus.
f120..................  Venison................  Capreolus capeolus.
f121..................  Pinto bean.............  Phaseolus vulgaris.
f122..................  Cheese, American.......  NA.
f127..................  Black-eyed pea.........  Vigna unguiculata.
f131..................  Black Olive............  Olea europaea.
f136..................  Red beet...............  Beta vulgaris var.
                                                  conditiva.
f139..................  Goat's Cheese..........  Capra aegagrus.
f140..................  Bran...................  NA.
f141..................  Corn (vegetables)......  Zea mays.
f152..................  Green bell pepper......  Capsicum annuum.
f155..................  Brewer's yeast.........  Saccharomyces
                                                  carlsbergensis.
f157..................  Duck...................  Anas domesticus.
f158..................  Goose..................  Anser anser.
f160..................  Camembert cheese.......  NA.

[[Page 31998]]

 
f162..................  Nectarine..............  Prunus persica var.
                                                  nucipersica.
f163..................  Kohlrabi...............  Brassica oleracea var.
                                                  gongylodes.
f65...................  Perch..................
f166..................  Leek...................  Allium porrum.
f170..................  Cheese (Switzerland)     NA.
                         (Swiss cheese).
f174..................  Fig....................  Ficus carica.
f177..................  Cranberry..............  Vaccinium macrocarpon.
f179..................  Raisin.................  Vitis spp.
f182..................  Lima bean..............  Phaseolus lunatus.
f198..................  Flaxseed (bruised        Linum usitatissimum.
                         grain).
f199..................  Untreated native milk..  Bos domesticus (Bos
                                                  taurus; Bos spp.).
f208..................  Lemon..................  Citrus limon.
f209..................  Grapefruit.............  Citrus paradisi.
f210..................  Pineapple..............  Ananas comosus.
f211..................  Blackberry.............  Rubus fruticosus.
f212..................  Mushroom (champignon)..  Agaricus hortensis
                                                 (Agaricus spp.).
f213..................  Rabbit.................  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
f214..................  Spinach................  Spinacia oleracea.
f215..................  Lettuce................  Lactuca sativa.
f216..................  Cabbage................  Brassica oleracea var.
                                                  capitata.
f217..................  Brussels sprouts.......  Brassica oleracea var.
                                                  gem.
f218..................  Paprika, sweet pepper..  Capsicum annuum.
f219..................  Fennel seed............  Foeniculum vulgare.
f219..................  Sage...................  Salvia officinalis.
f220..................  Cinnamon...............  Cinnamomum spp.
f221..................  Coffee.................  Coffea spp.
f222..................  Tea....................  Camellia sinensis.
f223..................  Green olive............  Olea europaea.
f225..................  Summer squash, pumpkin.  Cucurbita pepo.
f225..................  Pumpkin................  Cucurbita maxima.
f226..................  Pumpkin seed...........  Cucurbita pepo.
f227..................  Sugar-beet seed........  Beta vulgaris.
f229..................  Safflower Seed.........  Carthamus tinctorius.
f231..................  Milk, boiled...........  Bos domesticus
                                                 (Bos taurus; Bos spp.).
f234..................  Vanilla................  Vanilla planifolia.
f237..................  Apricot................  Prunus armeniaca.
f241..................  Gouda cheese...........  NA.
f242..................  Cherry.................  Prunus avium.
f244..................  Cucumber...............  Cucumis sativus.
f246..................  Guar, guar gum.........  Cyamopsis
                                                  tetragonoloba.
f247..................  Honey..................  NA.
f248..................  Rosemary...............  Rosmarinus officinalis.
f254..................  Plaice.................  Pleuronectes platessa.
f255..................  Plum...................  Prunus domestica
                                                 Prunus americana.
f258..................  Squid..................  Loligo spp.
f259..................  Grape..................  Vitis vinifera
                                                 (Vitis spp.).
f260..................  Broccoli...............  Brassica oleracea var.
                                                  italica (Brassica
                                                  oleracea var.
                                                  cultivar).
f261..................  Asparagus..............  Asparagus officinalis.
f262..................  Aubergine, eggplant....  Solanum melongena.
f263..................  Green pepper...........  Piper nigrum
                                                 Capsicum annuum.
f264..................  Eel....................  Anguilla anguilla.
f265..................  Caraway................  Carum carvi.
f265..................  Cumin..................  Cuminum cyminum.
f266..................  Mace...................  Myristica fragrans.
f267..................  Cardamon...............  Elettaria cardamomum.
f268..................  Clove..................  Syzygium aromaticum.
f269..................  Basil..................  Ocimum basilicum.
f270..................  Ginger.................  Zingiber officinale.
f271..................  Anise..................  Pimpinella anisum.
f272..................  Tarragon...............  Artemisia dracunculus.
f273..................  Thyme..................  Thymus vulgaris.
f274..................  Marjoram...............  Origanum majorana.
f275..................  Lovage.................  Levisticum officinale.
f276..................  Fennel, fresh..........  Foeniculum vulgare.

[[Page 31999]]

 
f277..................  Dill...................  Anethum graveolens.
f278..................  Bay leaf...............  Laurus nobilis.
f279..................  Chili pepper...........  Capsicum frutescens.
f280..................  Black pepper...........  Piper nigrum.
f281..................  Curry (Santa Maria)....  NA.
f282..................  Nutmeg.................  Myristica fragrans.
f283..................  Oregano................  Origanum vulgare.
f284..................  Turkey meat............  Meleagris gallopavo.
f285..................  Elk/moose meat.........  Alces spp.
f286..................  Mare's milk............  Equus caballus (Equus
                                                  spp.).
f287..................  Red kidney bean........  Phaseolus vulgaris.
f288..................  Blueberry..............  Vaccinium myrtillus
                                                  (Vaccinium spp.).
f289..................  Date...................  Phoenix dactylifera.
f291..................  Cauliflower............  Brassica oleracea var.
                                                  botrytis.
f292..................  Guava..................  Psidium guajava.
f293..................  Papaya.................  Carica papaya.
f294..................  Passion fruit, Maracuja  Passiflora edulis
                                                  (Passiflora spp.).
f295..................  Carambola..............  Averrhoa carambola.
f296..................  Carob..................  Ceratonia siliqua.
f297..................  Gum arabic.............  Acacia senegal (Acacia
                                                  spp.).
f298..................  Tragacanth.............  Astragalus spp.
f299..................  Sweet chestnut           Castanea sativa.
                         (chestnut).
f300..................  Pinto bean.............  Phaseolus spp.
f301..................  Persimmon (kaki fruit,   Diospyros kaki.
                         sharon).
f302..................  Mandarin (tangerine,     Citrus reticulata.
                         clementine, satsumas).
f305..................  Fenugreek..............  Trigonella foenum-
                                                  graecum.
f306..................  Lime...................  Citrus aurantifolia.
f307..................  Hake...................  Merluccius merluccius.
f308..................  Sardine (pilchard).....  Sardina pilchardus.
f310..................  Blue vetch.............  Lathyrus sativus.
f311..................  Megrim.................  Lepidorhombus
                                                  whiffiagonis.
f315..................  Green bean.............  Phaseolus vulgaris.
f316..................  Rape seed..............  Brassica napus.
f317..................  Coriander..............  Coriandrum sativum.
f318..................  Jack fruit.............  Artocarpus
                                                  heterophyllus.
f319..................  Beetroot...............  Beta vulgaris.
f320..................  Crayfish...............  Astacus astacus.
f321..................  Horse meat.............  Equus caballus (Equus
                                                  spp.).
f322..................  Red currant............  Ribes sylvestre.
f324..................  Hop (fruit cone).......  Humulus lupulus.
f325..................  Saffron................  Colchicum autumnale.
f328..................  Fig....................  Ficus carica.
f329..................  Watermelon.............  Citrullus lanatus.
f330..................  Rose hip...............  Rosa spp.
f331..................  Saffron................  Crocus sativus.
f332..................  Mint...................  Mentha piperita.
f333..................  Linseed................  Linum usitatissimum.
f336..................  Jujube.................  Ziziphus jujuba.
f336..................  Wine vinegar...........  Vitis vinifera (Vitis
                                                  spp.).
f337..................  Sole...................  Solea solea.
f337..................  English sole...........  Parophrys vetulus.
f338..................  Wine, white............  Vitis vinifera (Vitis
                                                  spp.).
f339..................  Allspice...............  Pimenta dioica.
f339..................  Wine, red..............  Vitis vinifera (Vitis
                                                  spp.).
f341..................  Cranberry..............  Vaccinium oxycoccus
                                                 Vaccinium macrocarpon.
f342..................  Olive (black, fresh)...  Olea europaea.
f343..................  Raspberry..............  Rubus idaeus.
f344..................  Sage...................  Salvia officinalis.
f346..................  Chives.................  Allium schoenoprasum.
f347..................  Quinoa.................  Chenopodium quinoa.
f348..................  Litchi.................  Litchi chinensis.
f349..................  Chum salmon roe........  Oncorhynchus keta.
f358..................  Artichoke..............  Cynara scolymus.
f360..................  Yogurt.................  NA.
f368..................  Black bass.............  Micropterus dolomieu
                                                  (Micropterus
                                                  dolomieui).
f374..................  Karaya gum.............  Sterculia urens.
f375..................  Horseradish............  Armoracia rusticana.
f377..................  Maple syrup............  NA.
f379..................  Okra...................  Abelmoschus esculentus.

[[Page 32000]]

 
f382..................  Beet, sugar............  Beta vulgaris var.
                                                  altissima.
f401..................  Loquat.................  Eriobotrya japonica.
f402..................  Fig....................  Ficus carica.
f403..................  Brewer's yeast.........  Saccharomyces
                                                  cerevisiae.
f405..................  Mint...................  Mentha spp.
f406..................  Arugula................  Eruca vesicaria.
------------------------------------------------------------------------
                               House Dust
------------------------------------------------------------------------
h1....................  Greer Labs., Inc.......  NA.
h2....................  Hollister-Stier Labs...  NA.
h6....................  Japan..................  NA.
------------------------------------------------------------------------
                            Venoms & Insects
------------------------------------------------------------------------
i7....................  Midge..................  Chironomus yoshimatsui.
i8....................  Moth...................  Bombyx mori
                                                 Heterocera spp.
i47...................  Water flea.............  Daphnia spp.
i49...................  Deer fly...............  Chrysops spp.
i51...................  Black ant..............  Camponotus
                                                  pennsylvanicus.
i54...................  Flea mix (dog/cat),      Ctenocephalides spp.
                         common flea.
i71...................  Mosquito...............  Aedes communis
                                                 Aedes spp. and Culex
                                                  spp.
i72...................  Green nimitti..........  Cladotanytarsus lewisi.
i73...................  Blood worm.............  Chironomus thummi
                                                 Chironomusri parius
                                                 Chironomus spp.
i75...................  European hornet........  Vespa crabro.
i76...................  Berlin beetle..........  Trogoderma angustum.
i77...................  European paper wasp....  Polistes dominulus.
i78...................  Fly....................  Musca domestica.
i80...................  Bumblebee..............  Bombus pennsylvanicus.
i201..................  Horse bot fly..........  Gasterophilus
                                                  intestinalis.
i202..................  Grain weevil...........  Sitophilus granarius.
i203..................  Mediterranean flour      Ephestia kuehniella
                         moth.                    (Anagasta kuehniella).
i204..................  Horse fly..............  Tabanus spp.
i205..................  Bumblebee..............  Bombus terrestris.
i208..................  Api m 1.0101...........  Apis mellifera.
a45...................  Api m 1................  Apis mellifera.
i209..................  Ves v 5.0101...........  Vespula vulgaris.
a670..................  Ves v 5................  Vespula vulgaris.
i210..................  Pol d 5.0101...........  Polistes dominulus.
i211..................  Ves v 1.0101...........  Vespula vulgaris.
i213..................  Api m 4................  Apis mellifera.
i214..................  Api m 2................  Apis mellifera.
i215..................  Api m 3................  Apis mellifera.
i216..................  Api m 5................  Apis mellifera.
i217..................  Api m 10...............  Apis mellifera.
i220..................  Bla g 1.0101...........  Blattella germanica.
i221..................  Bla g 2.0101...........  Blattella germanica.
i222..................  Bla g 5.0101...........  Blattella germanica.
i223..................  Bla g 7................  Blattella germanica
a46...................  Api m 2................  Apis mellifera.
------------------------------------------------------------------------
                              Miscellaneous
------------------------------------------------------------------------
o1....................  Cotton, crude fibers...  Gossypium spp.
o3....................  Cotton (treated).......  Gossypium spp.
o70...................  Seminal fluid..........  Homo sapiens.
o71...................  Staphylococcus aureus..  Staphylococcus aureus.
o72...................  Pichia pastoris crude    Pichia pastoris.
                         extract customer
                         specific.
o72...................  Sperm-sediment.........  Homo sapiens.
o73...................  Pichia pastoris crude    Pichia pastoris.
                         extr. vector customer
                         specific.
o74...................  Pichia pastoris with     Pichia pastoris.
                         vector customer
                         specific.
o201..................  Tobacco leaf, tobacco    Nicotiana tabacum.
                         dust.
o202..................  Artemia salina, fish     Artemia salina.
                         feed.
o203..................  Tetramin, fish feed....  NA.
o207..................  Daphnia, fish feed.....  Daphnia spp.
o211..................  Mealworm...............  Tenebrio molitor.

[[Page 32001]]

 
o212..................  Streptavidin...........  Streptomyces avidini.
o213..................  MBP (maltose binding     Escherichia coli.
                         protein).
o214..................  CCD; MUXF3 from          Ananas comosus.
                         bromelain.
o72...................  Enterotoxin A (Sta a     Staphylococcus aureus.
                         SEA).
o73...................  Enterotoxin B (Sta a     Staphylococcus aureus.
                         SEB).
------------------------------------------------------------------------
                                Parasites
------------------------------------------------------------------------
p1....................  Ascaris................  Ascaris suum.
p2....................  Echinococcus...........  Echinococcus
                                                  granulosus.
p3....................  Schistosoma............  Schistosoma mansoni.
p4....................  Anisakis (Herring Worm)  Anisakis simplex
                                                  (Anisakis spp.).
p5....................  Toxocara canis.........  Toxocara canis.
p10...................  Ani s 3.0101...........  Anisakis simplex
                                                  (Anisakis spp.).
p11...................  Ani s 1................  Anisakis simplex
                                                  (Anisakis spp.).
------------------------------------------------------------------------
                              Occupational
------------------------------------------------------------------------
k4....................  Threshing dust.........  NA.
k5....................  Flax...................  NA.
k7....................  Hay Dust...............  NA.
k8....................  Hop (hops).............  Humulus lupulus.
k12...................  Grain mill dust........  NA.
k14...................  Kapok..................  NA.
k20...................  Sheep's wool (treated)   Ovis aries (Ovis spp.).
                         (wool).
k21...................  Sheep's wool             Ovis aries (Ovis spp.).
                         (Untreated).
k23...................  Straw Dust.............  NA.
k33...................  Oak....................  NA.
k70...................  Green coffee bean......  Coffea spp.
k71...................  Castor bean............  Ricinus communis.
k72...................  Ispaghula..............  Plantago psyllium/
                                                  Plantago ovata.
k73...................  Silk waste.............  NA.
k74...................  Silk...................  Bombyx mori.
k75...................  Isocyanate TDI (Toluene  NA.
                         diisocyanate).
k76...................  Isocyanate MDI           NA.
                         (Diphenylmethane
                         diisocyanate).
k77...................  Isocyanate HDI           NA.
                         (Hexamethylen
                         diisocyanate).
k78...................  Ethylene oxide.........  NA.
k79...................  Phthalic anhydride.....  NA.
k80...................  Formaldehyde/Formalin..  NA.
k81...................  Ficus..................  Ficus benjamina (Ficus
                                                  spp.).
k83...................  Cotton seed............  Gossypium hirsutum.
k84...................  Sunflower seed.........  Helianthus annuus.
k85...................  Chloramin T............  NA.
k86...................  Trimellitic anhydride,   NA.
                         TMA.
k87...................  Asp o 21, alpha-amylase  Aspergillus oryzae.
k89...................  Orris root.............  Iris florentina.
k99...................  HSA (Human Serum         Homo sapiens.
                         Albumin) (Hom s HSA).
k201..................  Car p 1, Papain........  Carica papaya.
k202..................  Ana c 2, Bromelain.....  Ananas comosus.
k204..................  Maxatase...............  Bacillus licheniformis.
k205..................  Alcalase...............  Bacillus spp.
k206..................  Savinase, Protease 1     Bacillus spp.
                         (Bac l Subtilisin).
k208..................  Gal d 4, Lysozyme......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
k209..................  Hexahydrophtalic         NA.
                         anhydrid.
k210..................  Maleic anhydride.......  NA.
k211..................  Methyltetrahydrophtalic  NA.
                         anhydrid.
k212..................  Abachi wood dust.......  Triplochiton
                                                  scleroxylon.
k213..................  Pepsin (Sus s Pepsin)..  Sus scrofa (Sus scrofa
                                                  domesticus; Sus spp.).
k213..................  TCPA...................  NA.
k214..................  Bougainvillea..........  Bougainvillea spp.
k225..................  Horse radish peroxidase  Armoracia rusticana.
                         (Arm r HRP).
k226..................  Ascorbate oxidase (Cuc   Cucurbita pepo.
                         p ascorbate oxidase).
k301..................  Flour dust.............  Triticum spp.
k501..................  Savinase customer        Proprietary knowledge
                         specific.                of customer.
k502..................  Lipolase customer        Proprietary knowledge
                         specific.                of customer.
k503..................  Termamyl customer        Proprietary knowledge
                         specific.                of customer.
k504..................  Clazinase customer       Proprietary knowledge
                         specific.                of customer.
------------------------------------------------------------------------


[[Page 32002]]

V. Reference

    The following reference is on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions From 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]
 BILLING CODE 4164-01-P


