[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Rules and Regulations]
[Pages 71794-71819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 
884, 886, 888, 890, and 892

[Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610]


Medical Devices; Exemptions From Premarket Notification for Class 
I and Class II Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 
identified a list of class I devices and class II devices that are now 
exempt from premarket notification requirements, subject to certain 
limitations. FDA published the lists of final determinations in 
accordance with procedures established by the 21st Century Cures Act 
(Cures Act). Although each classification regulation for each such type 
of device shall be deemed amended to incorporate such exemption, we are 
publishing this final order to amend the codified language for each 
listed class I and class II device's classification regulation to 
reflect the final determinations. FDA's action decreases regulatory 
burden on the medical device industry and eliminates private costs and 
expenditures required to comply with certain Federal regulations.

DATES: This order is effective December 30, 2019.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-
9603, email: karen.fikes@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Cures Act (Pub. L. 114-255) was signed into law on December 13, 
2016. Under the Cures Act, section 3054 amended section 510(l) and (m) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires 
FDA to identify through publication in the Federal Register, any type 
of class I device that the Agency determines no longer requires a 
report under section 510(k) of the FD&C Act to provide reasonable 
assurance of safety and effectiveness.

[[Page 71795]]

FDA shall publish this determination within 120 days of the date of 
enactment of the Cures Act and at least once every 5 years thereafter, 
as FDA determines appropriate. Further, section 510(l)(2) provides that 
upon the date of publication of the Agency's determination in the 
Federal Register, a 510(k) will no longer be required for these devices 
and the classification regulation applicable to each such type of 
device shall be deemed amended to incorporate such exemption.
    As amended, section 510(m)(1)(A) of the FD&C Act provides that, 
within 90 days after enactment of the Cures Act and at least once every 
5 years thereafter, FDA shall 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 to 
provide reasonable assurance of safety and effectiveness. This notice 
shall provide at least a 60-day comment period. Within 210 days of 
enactment of the Cures Act, FDA shall publish in the Federal Register a 
list representing its final determination regarding exemption of 
devices that were contained in the proposed list published under 
510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C 
Act provides that upon the date of publication of the final list in the 
Federal Register, a 510(k) will no longer be required for these devices 
and the classification regulation applicable to each such device shall 
be deemed amended to incorporate such exemption.
    In the Federal Register of April 13, 2017 (82 FR 17841), in 
accordance with the amendments to 510(l)(2), FDA issued a notice of 
final determination to exempt a list of class I devices from premarket 
notification requirements under section 510(k) of the FD&C Act, subject 
to certain limitations. In the Federal Register of March 14, 2017 (82 
FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA 
issued a notice proposing to exempt a list of class II devices from 
premarket notification requirements under section 510(k) of the FD&C 
Act, subject to certain limitations. After a 60-day comment period, in 
the Federal Register of July 11, 2017 (82 FR 31976), FDA issued a 
notice of final determination to exempt class II devices provided in 
the proposed list. Through this action, FDA is now amending the 
codified language for each listed classification regulation to reflect 
final determinations for these class I and class II exemptions.\1\
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    Following publication of the notices, FDA determined that it is 
unnecessary to update three classification regulations (21 CFR 
872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I 
notice, 82 FR 17841. Five product codes corresponding to these three 
classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR 
878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption 
in 82 FR 17841; however, the corresponding classification regulations 
were already class I, exempt from premarket notification procedures in 
subpart E of part 807 (21 CFR part 807, subpart E) subject to the 
limitations in the corresponding ``.9'' regulations (i.e., 21 CFR 
872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to 
the codified are necessary. Additionally, we determined that it is 
unnecessary to update 21 CFR 876.5820 included in the class II notice, 
82 FR 13609. The product code within this classification regulation 
(FKI) was identified for exemption in 82 FR 13609. However, this device 
type is specifically identified within the class I paragraph of this 
classification regulation (21 CFR 876.5820(b)(2)) and already exempt 
from premarket notification procedures in subpart E of part 807 subject 
to the limitations in 21 CFR 876.9. Therefore, no revisions to the 
codified are necessary.
    We are also making a revision to correct a misidentified 
classification regulation in 82 FR 31976. The notice incorrectly listed 
the classification regulation 21 CFR 868.1400 ``Carbon dioxide gas 
analyzer'' as corresponding with product code LLK; however, the correct 
classification regulation associated with product code LLK is 21 CFR 
880.5780 ``Medical Support Stocking''. Therefore, 21 CFR 868.1400 
remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the 
exemption.
    We are revising the name of one classification regulation, 
currently entitled ``Urological clamp for males'', in response to FDA's 
exemption in 82 FR 17841. Part 876.5160 is currently entitled 
``Urological clamp for males,'' which was previously exempt from 
premarket notification procedures ``. . . Except when intended for 
internal use or use on females . . .''. In 82 FR 17841, we exempted 
product code MNG, ``External Urethral Occluder, Urinary Incontinence-
Control, Female'' and removed the current limitation language regarding 
``use on females.'' Therefore, FDA is revising the name of the 
classification regulation to read ``Urological clamp'' to ensure 
clarity.

II. Criteria for Exemption

    As amended by the Cures Act, section 510(l) now has two provisions, 
510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the 
premarket notification requirements under section 510(k) of the FD&C 
Act, unless the device is intended for a use which is of substantial 
importance in preventing impairment of human health or it presents a 
potential unreasonable risk of illness or injury. Based on these 
criteria, FDA evaluated all class I devices to determine which device 
types should be exempt from premarket notification requirements.
    For class II devices, 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 we issued 
on February 19, 1998, entitled ``Procedures for Class II Device 
Exemptions From Premarket Notification, Guidance for Industry and CDRH 
Staff ''.\2\
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    \2\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
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III. Limitations on Exemptions

    Although FDA exempted the types of class I and class II devices 
from the premarket notification requirements under section 510(k) of 
the FD&C Act in accordance with the provisions under 510(l) and (m), an 
exemption from the requirement of premarket notification does not mean 
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 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 21 CFR 862.9 to 892.9, FDA has also partially 
limited some exemptions from premarket notification requirements to 
specific devices within

[[Page 71796]]

the 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.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

    This final order refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 
part 807, subpart E, regarding premarket notification submissions, have 
been approved under OMB control number 0910-0120; the collections of 
information in 21 CFR parts 801 and 809, regarding labeling, have been 
approved under OMB control number 0910-0485; and the collections of 
information in 21 CFR part 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 
890

    Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and Containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 
890, and 892 are amended as follow:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. In Sec.  862.1020, revise paragraph (b) to read as follows:


Sec.  862.1020  Acid phosphatase (total or prostatic) test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
3. In Sec.  862.1090, revise paragraph (b) to read as follows:


Sec.  862.1090  Angiotensin converting enzyme (A.C.E.) test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
4. In Sec.  862.1100, revise paragraph (b) to read as follows:


Sec.  862.1100  Aspartate amino transferase (AST/SGOT) test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
5. In Sec.  862.1150, revise paragraph (b) to read as follows:


Sec.  862.1150  Calibrator.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
6. In Sec.  862.1345, revise paragraph (b) to read as follows:


Sec.  862.1345  Glucose test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
7. In Sec.  862.1350, revise paragraph (b) introductory text to read as 
follows:


Sec.  862.1350  Continuous glucose monitor secondary display.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9. The 
special controls for this device are:
* * * * *

0
8. In Sec.  862.1410, revise paragraph (b) to read as follows:


Sec.  862.1410  Iron (non-heme) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
9. In Sec.  862.1415, revise paragraph (b) to read as follows:


Sec.  862.1415  Iron-binding capacity test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
10. In Sec.  862.1445, revise paragraph (b) to read as follows:


Sec.  862.1445  Lactate dehydrogenase isoenzymes test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
11. In Sec.  862.1509, revise paragraph (b) to read as follows:


Sec.  862.1509  Methylmalonic acid (nonquantitative) test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
12. In Sec.  862.1580, revise paragraph (b) to read as follows:


Sec.  862.1580  Phosphorous (inorganic) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
13. In Sec.  862.1660, revise paragraph (b) to read as follows:


Sec.  862.1660  Quality control material (assayed and unassayed).

* * * * *
    (b) Classification. Class I (general controls). Except when 
intended for use in donor screening tests, quality control materials 
(assayed and unassayed) are

[[Page 71797]]

exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
14. In Sec.  862.1685, revise paragraph (b) as follows:


Sec.  862.1685  Thyroxine-binding globulin test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
15. In Sec.  862.1700, revise paragraph (b) as follows:


Sec.  862.1700  Total thyroxine test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
16. In Sec.  862.1775, revise paragraph (b) to read as follows:


Sec.  862.1775  Uric acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
17. In Sec.  862.2265, revise paragraph (b) introductory text to read 
as follows:


Sec.  862.2265  High throughput genomic sequence analyzer for clinical 
use.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9. The 
special controls for this device are:
* * * * *

0
18. In Sec.  862.2570, revise paragraph (b) to read as follows:


Sec.  862.2570  Instrumentation for clinical multiplex test systems.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Instrumentation for Clinical Multiplex Test 
Systems.'' See Sec.  862.1(d) for the availability of this guidance 
document.

0
19. In Sec.  862.3050, revise paragraph (b) to read as follows:


Sec.  862.3050  Breath-alcohol test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
20. In Sec.  862.3100, revise paragraph (b) to read as follows:


Sec.  862.3100  Amphetamine test system.

* * * * *
    (b) Classification. Class II (special controls). An amphetamine 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
21. In Sec.  862.3150, revise paragraph (b) to read as follows:


Sec.  862.3150  Barbiturate test system.

* * * * *
    (b) Classification. Class II (special controls). A barbiturate test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
22. In Sec.  862.3170, revise paragraph (b) to read as follows:


Sec.  862.3170  Benzodiazepine test system.

* * * * *
    (b) Classification. Class II (special controls). A benzodiazepine 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
23. In Sec.  862.3200, revise paragraph (b) to read as follows:


Sec.  862.3200  Clinical toxicology calibrator.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
24. In Sec.  862.3220, revise paragraph (b) to read as follows:


Sec.  862.3220  Carbon monoxide test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
25. In Sec.  862.3240, revise paragraph (b) to read as follows:


Sec.  862.3240  Cholinesterase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
26. In Sec.  862.3250, revise paragraph (b) to read as follows:


Sec.  862.3250  Cocaine and cocaine metabolite test system.

* * * * *
    (b) Classification. Class II (special controls). A cocaine and 
cocaine metabolite test system is not exempt if it is intended for any 
use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  862.9, provided the test system is 
intended for employment and insurance testing and includes a statement 
in the labeling that the device is intended solely for use in 
employment and insurance testing, and does not include devices intended 
for Federal drug testing programs (e.g.,

[[Page 71798]]

programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and 
the U.S. military).

0
27. In Sec.  862.3270, revise paragraph (b) to read as follows:


Sec.  862.3270  Codeine test system.

* * * * *
    (b) Classification. Class II (special controls). A codeine test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
28. In Sec.  862.3280, revise paragraph (b) to read as follows:


Sec.  862.3280  Clinical toxicology control material.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
29. In Sec.  862.3580, revise paragraph (b) to read as follows:


Sec.  862.3580  Lysergic acid diethylamide (LSD) test system.

* * * * *
    (b) Classification. Class II (special controls). A lysergic acid 
diethylamide (LSD) test system is not exempt if it is intended for any 
use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  862.9, provided the test system is 
intended for employment and insurance testing and includes a statement 
in the labeling that the device is intended solely for use in 
employment and insurance testing, and does not include devices 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).

0
30. In Sec.  862.3610, revise paragraph (b) to read as follows:


Sec.  862.3610  Methamphetamine test system.

* * * * *
    (b) Classification. Class II (special controls). A methamphetamine 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
31. In Sec.  862.3620, revise paragraph (b) to read as follows:


Sec.  862.3620  Methadone test system.

* * * * *
    (b) Classification. Class II (special controls). A methadone test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
32. In Sec.  862.3630, revise paragraph (b) to read as follows:


Sec.  862.3630  Methaqualone test system.

* * * * *
    (b) Classification. Class II (special controls). A methaqualone 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
33. In Sec.  862.3640, revise paragraph (b) to read as follows:


Sec.  862.3640  Morphine test system.

* * * * *
    (b) Classification. Class II (special controls). A morphine test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
34. In Sec.  862.3650, revise paragraph (b) to read as follows:


Sec.  862.3650  Opiate test system.

* * * * *
    (b) Classification. Class II (special controls). An opiate test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
35. In Sec.  862.3700, revise paragraph (b) to read as follows:


Sec.  862.3700  Propoxyphene test system.

* * * * *

[[Page 71799]]

    (b) Classification. Class II (special controls). A propoxyphene 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
36. In Sec.  862.3870, revise paragraph (b) to read as follows:


Sec.  862.3870  Cannabinoid test system.

* * * * *
    (b) Classification. Class II (special controls). A cannabinoid test 
system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices 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).

0
37. In Sec.  862.3910, revise paragraph (b) to read as follows:


Sec.  862.3910  Tricyclic antidepressant drugs test system.

* * * * *
    (b) Classification. Class II (special controls). A tricyclic 
antidepressant drugs test system is not exempt if it is intended for 
any use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  862.9, provided the test system is 
intended for employment and insurance testing and includes a statement 
in the labeling that the device is intended solely for use in 
employment and insurance testing, and does not include devices 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).

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
38. The authority citation for part 864 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
39. In Sec.  864.5400, revise paragraph (b) to read as follows:


Sec.  864.5400  Coagulation instrument.

* * * * *
    (b) Classification. Class II (special controls). A fibrometer or 
coagulation timer intended for use with a coagulation instrument is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
40. In Sec.  864.5425, revise paragraph (b) to read as follows:


Sec.  864.5425  Multipurpose system for in vitro coagulation studies.

* * * * *
    (b) Classification. Class II (special controls). A control intended 
for use with a multipurpose system for in vitro coagulation studies is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
41. In Sec.  864.6550, revise paragraph (b) to read as follows:


Sec.  864.6550  Occult blood test.

* * * * *
    (b) Classification. Class II (special controls). A control intended 
for use with an occult blood test is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  864.9.

0
42. In Sec.  864.7040, revise paragraph (b) to read as follows:


Sec.  864.7040  Adenosine triphosphate release assay.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
43. In Sec.  864.7275, revise paragraph (b) to read as follows:


Sec.  864.7275  Euglobulin lysis time tests.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
44. In Sec.  864.7300, revise paragraph (b) to read as follows:


Sec.  864.7300  Fibrin monomer paracoagulation test.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9. The 
special control for this device is FDA's ``In Vitro Diagnostic Fibrin 
Monomer Paracoagulation Test.'' See Sec.  864.1(d) for information on 
obtaining this document.

0
45. In Sec.  864.7340, revise paragraph (b) to read as follows:


Sec.  864.7340  Fibrinogen determination system.

* * * * *
    (b) Classification. Class II (special controls). A control or 
fibrinogen standard intended for use with a fibrinogen determination 
system is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
864.9.

0
46. In Sec.  864.7375, revise paragraph (b) to read as follows:


Sec.  864.7375  Glutathione reductase assay.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
47. In Sec.  864.7415, revise paragraph (b) to read as follows:


Sec.  864.7415  Abnormal hemoglobin assay.

* * * * *
    (b) Classification. Class II (special controls). A control intended 
for use with an abnormal hemoglobin assay is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  864.9.

0
48. In Sec.  864.7455, revise paragraph (b) to read as follows:


Sec.  864.7455  Fetal hemoglobin assay.

* * * * *
    (b) Classification. Class II (special controls). A fetal hemoglobin 
stain intended for use with a fetal hemoglobin assay is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  864.9.

0
49. In Sec.  864.7500, revise paragraph (b) to read as follows:

[[Page 71800]]

Sec.  864.7500  Whole blood hemoglobin assays.

* * * * *
    (b) Classification. Class II (special controls). An acid hematin 
intended for use with whole blood hemoglobin assays is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  864.9.

0
50. In Sec.  864.7720, revise paragraph (b) to read as follows:


Sec.  864.7720  Prothrombin consumption test.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
51. In Sec.  864.7735, revise paragraph (b) to read as follows:


Sec.  864.7735  Prothrombin-proconvertin test and thrombotest.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
52. In Sec.  864.8150, revise paragraph (b) to read as follows:


Sec.  864.8150  Calibrator for cell indices.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
53. In Sec.  864.8165, revise paragraph (b) to read as follows:


Sec.  864.8165  Calibrator for hemoglobin or hematocrit measurement.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
54. In Sec.  864.8175, revise paragraph (b) to read as follows:


Sec.  864.8175  Calibrator for platelet counting.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
55. In Sec.  864.8185, revise paragraph (b) to read as follows:


Sec.  864.8185  Calibrator for red cell and white cell counting.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

0
56. In Sec.  864.8625, revise paragraph (b) to read as follows:


Sec.  864.8625  Hematology quality control mixture.

* * * * *
    (b) Classification. Class II (special controls). Except when 
intended for use in blood components, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  864.9.

0
57. In Sec.  864.9400, revise paragraph (b) to read as follows:


Sec.  864.9400  Stabilized enzyme solution.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  864.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
58. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
59. In Sec.  866.2900, revise paragraph (b) to read as follows:


Sec.  866.2900  Microbiological specimen collection and transport 
device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9.

0
60. In Sec.  866.3395, revise paragraph (b) to read as follows:


Sec.  866.3395  Norovirus serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Norovirus Serological Reagents.'' See Sec.  
866.1(e) for the availability of this guidance document.

0
61. In Sec.  866.5210, revise paragraph (b) to read as follows:


Sec.  866.5210  Ceruloplasmin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9.

0
62. In Sec.  866.5470, revise paragraph (b) to read as follows:


Sec.  866.5470  Hemoglobin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9.

0
63. In Sec.  866.5620, revise paragraph (b) to read as follows:


Sec.  866.5620  Alpha-2-macroglobulin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9.

0
64. In Sec.  866.5630, revise paragraph (b) to read as follows:


Sec.  866.5630  Beta-2-microglobulin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9.

0
65. In Sec.  866.5750, revise paragraph (b) to read as follows:


Sec.  866.5750  Radioallergosorbent (RAST) immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
intended to detect any of the allergens included in Table 1 in this 
paragraph, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  866.9.

[[Page 71801]]



       Table 1--Class II Exempt Allergens Under Sec.   866.5750--
          Radioallergosorbent (RAST) Immunological Test Systems
------------------------------------------------------------------------
                                                            Source
          Allergen code            Allergen product   (taxonomical name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1..............................  Sweet vernal grass  Anthoxanthum
                                                       odoratum.
g3..............................  Cocksfoot grass,    Dactylis
                                   Orchard grass.      glomerata.
g4..............................  Meadow fescue.....  Festuca elatior.
g5..............................  Rye-grass           Lolium perenne.
                                   (perennial rye
                                   grass).
g7..............................  Common reed         Phragmites
                                   (common reed        communis.
                                   grass).
g8..............................  Meadow grass,       Poa pratensis.
                                   Kentucky blue
                                   (June grass).
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      Alopecurus
                                   (meadow foxtail     pratensis.
                                   grass).
g17.............................  Bahia grass.......  Paspalum notatum.
g24.............................  Wheat grass,        Agropyron smithii
                                   Western.            (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         Zea mays.
                                   (cultivated corn).
g203............................  Salt grass........  Distichlis
                                                       spicata.
g204............................  False oat-grass...  Arrhenatherum
                                                       elatius.
g216............................  Cyn d 1...........  Cynodon dactylon.
g701............................  Phl p 1.0102, Phl   Phleum pratense.
                                   p 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            Plantago
                                   (English),          lanceolata.
                                   Ribwort.
w10.............................  Goosefoot, lamb's   Chenopodium album.
                                   quarters.
w11.............................  Saltwort            Salsola kali
                                   (prickly),          (Salsola
                                   Russian thistle.    pestifer).
w12.............................  Goldenrod.........  Solidago virgaurea
                                                       (Solidago spp.).
w13.............................  Cocklebur, common.  Xanthium commune.
w14.............................  Common pigweed      Amaranthus
                                   (rough pigweed).    retroflexus.
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      Urtica dioica.
                                   stinging nettle).
w21.............................  Wall pellitory....  Parietaria
                                                       judaica.
w22.............................  Japanese hop        Humulus japonicas
                                   (careless weed).    (Humulus
                                                       scandens).
w23.............................  Yellow dock,        Rumex crispus.
                                   Yellow 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,         Amaranthus rudis
                                   Western.            (Acnida
                                                       tamariscina).
w41.............................  Burrobrush........  Hymenoclea
                                                       salsola.
w42.............................  Poverty weed......  Baccharis
                                                       neglecta.
w43.............................  Common sagebrush..  Artemisia
                                                       tridentata.
w45.............................  Alfalfa...........  Medicago sativa.
w46.............................  Dog fennel........  Eupatorium
                                                       capillifolium.
w53.............................  Geranium..........  Geranium spp.
w67.............................  Groundsel bush....  Baccharis
                                                       halimifolia.
w69.............................  Iodine bush.......  Allenrolfea
                                                       occidentalis.
w70.............................  Ragweed, slender..  Ambrosia
                                                       confertiflora.
w75.............................  Wing scale          Atriplex
                                   (wingscale).        canescens.

[[Page 71802]]

 
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,         Alnus incana.
                                   speckled alder
                                   (alder).
t4..............................  Hazel, hazelnut...  Corylus avellana,
                                                       Corylus
                                                       americana.
t5..............................  American beech      Fagus grandifolia
                                   (beech).            (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          Platanus
                                   sycamore, London    acerifolia.
                                   plane, Plane tree.
t61.............................  Sycamore..........  Platanus
                                                       occidentalis.
t12.............................  Willow............  Salix caprea,
                                                       Salix nigra.
t14.............................  Cottonwood          Populus deltoides.
                                   (Eastern
                                   Cottonwood/Black
                                   Cottonwood).
t15.............................  White ash.........  Fraxinus
                                                       americana.
t16.............................  White pine........  Pinus strobus.
t18.............................  Eucalyptus, gum-    Eucalyptus
                                   tree.               globulus
                                                       (Eucalyptus
                                                       spp.).
t19/t26.........................  Acacia............  Acacia longifolia
                                                       (Acacia spp.).
t20.............................  Mesquite..........  Prosopis
                                                       glandulosa/
                                                       Prosopis
                                                       juliflora.
t21.............................  Melaleuca, cajeput  Melaleuca
                                   tree.               quinquenervia
                                                       (Melaleuca
                                                       leucadendron).
t22.............................  Pecan, hickory....  Carya
                                                       illinoinensis
                                                       (Carya pecan).
t23.............................  Italian/            Cupressus
                                   Mediterranean/      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        Taxodium
                                   (white bald         distichum.
                                   cypress).
t38.............................  Elm, Chinese/       Ulmus pumila.
                                   Siberian.
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.
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.

[[Page 71803]]

 
t77.............................  Oak mix (red,       Quercus spp.
                                   white, black).
t80.............................  Japanese cypress..  Chamaecyparis
                                                       obtusa.
t81.............................  Japanese alder....  Alnus japonica.
t83.............................  Mango tree........  Mangifera indica.
t90.............................  Walnut, black.....  Juglans nigra.
t96.............................  Poplar, white       Populus alba.
                                   (poplar).
t103/t218.......................  Virginia live oak   Quercus
                                   (live oak).         virginiana.
t105............................  Pepper tree.......  Schinus molle.
t110............................  Orange tree.......  Citrus sinensis.
t201............................  Spruce, Norway      Picea abies (Picea
                                   spruce.             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   Betula verrucosa
                                   v 4.                (Birch).
t222............................  Cypress (Arizona    Cupressus
                                   cypress).           arizonica.
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           Schinus
                                   peppertree.         terebinthifolius.
t402............................  Mastic tree.......  Pistacia
                                                       lentiscus.
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         Penicillium
                                   chrysogenum         chrysogenum
                                   (Penicillium        (Penicillium
                                   notatum).           notatum).
m2..............................  Cladosporium        Cladosporium
                                   herbarum            herbarum
                                   (Hormodendrum).     (Hormodendrum).
m3..............................  Aspergillus         Aspergillus
                                   fumigatus.          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).

[[Page 71804]]

 
m9..............................  Fusarium            Fusarium
                                   moniliforme         moniliforme
                                   (Fusarium           (Fusarium
                                   proliferatum).      proliferatum).
m10.............................  Stemphylium         Stemphylium
                                   botryosum.          herbarum
                                                       (Stemphylium
                                                       botryosum).
m11.............................  Rhizopus nigricans  Rhizopus
                                                       nigricans.
m12.............................  Aureobasidium       Aureobasidium
                                   pullulans.          pullulans.
m13.............................  Phoma betae.......  Phoma betae.
m14.............................  Epicoccum           Epicoccum
                                   purpurascens.       purpurascens
                                                       (Epicoccum
                                                       nigrum).
m15.............................  Trichoderma viride  Trichoderma
                                                       viride.
m16.............................  Curvularia lunata.  Curvularia lunata,
                                                       Curvularia
                                                       specifera
                                                       (K923044).
m17.............................  Cladosporium        Cladosporium
                                   fulvum.             fulvum.
m18.............................  Fusarium culmorum.  Fusarium culmorum.
m19.............................  Aspergillus         Aspergillus
                                   versicolor.         versicolor.
m20.............................  Mucor mucedo......  Mucor mucedo.
m21.............................  Aspergillus         Aspergillus
                                   clavatus.           clavatus.
m22.............................  Micropolyspora      Saccharopolyspora
                                   faeni.              rectivirgula
                                                       (Micropolyspora
                                                       faeni).
m23.............................  Thermoactinomyces   Thermoactinomyces
                                   vulgaris.           vulgaris.
m24.............................  Stachybotrys atra.  Stachybotrys
                                                       chartarum
                                                       (Stachybotrys
                                                       atra).
m24.............................  Paecilomyces spp..  Paecilomyces spp.
m25.............................  Aspergillus         Aspergillus
                                   versicolor.         versicolor.
m25.............................  Penicillium         Penicillium
                                   brevicompactum.     brevicompactum.
m26.............................  Cladosporium        Cladosporium
                                   cladosporioides.    cladosporioides.
m26.............................  Penicillium         Penicillium
                                   citrinum.           citrinum.
m27.............................  Penicillium spp...  Penicillium spp.
m29.............................  Aspergillus repens  Aspergillus
                                                       repens.
m30.............................  Penicillium         Penicillium
                                   roqueforti.         roqueforti.
m32.............................  Cladosporium        Cladosporium
                                   cladosporioides.    cladosporioides.
m34.............................  Serpula lacrymans.  Serpula lacrymans.
m36.............................  Aspergillus         Aspergillus
                                   terreus.            terreus.
m37.............................  Trichophyton        Trichophyton
                                   mentagrophytes.     mentagrophytes.
m40.............................  Aspergillus         Aspergillus
                                   amstelodami.        amstelodami.
m43.............................  Saccharomyces       Saccharomyces
                                   Carlsberg.          carlsbergensis.
m44.............................  Saccharomyces       Saccharomyces
                                   cerevisiae.         cerevisiae.
m45.............................  Hormodendrum        Hormodendrum
                                   hordei.             hordei.
m46.............................  Bipolaris           Bipolaris
                                   spicifera.          spicifera.
m47.............................  Aspergillus         Aspergillus
                                   nidulans.           nidulans.
m48.............................  Aspergillus oryzae  Aspergillus
                                                       oryzae.
m49.............................  Fusarium oxysporum  Fusarium
                                                       oxysporum.
m50.............................  Micropolyspora      Saccharopolyspora
                                   faeni.              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.
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
                                   enterotoxin A       aureus.
                                   (Sta a SEA).
m80.............................  Helminthosporium    Helminthosporium
                                   spp.                spp.
m81.............................  Staphylococcal      Staphylococcus
                                   enterotoxin B       aureus.
                                   (Sta a SEB).
m88.............................  Stemphylium solani  Stemphylium
                                                       solani.
m93.............................  Gliocladium         Gliocladium
                                   fimbriatum.         fimbriatum.
m94.............................  Phycomyces          Phycomyces
                                   blakesleeanus.      blakesleeanus.
m201............................  Tilletia tritici    Tilletia tritici
                                   (Ustilago nuda,     (Ustilago nuda,
                                   Ustilago tritici)   Ustilago
                                   (Barley smut).      tritici).
m202............................  Acremonium          Acremonium
                                   kiliense            kiliense
                                   (Cephalosporium     (Cephalosporium
                                   acremonium).        acremonium).
m203............................  Trichosporon        Trichosporon
                                   pullulans.          pullulans.
m204............................  Ulocladium          Ulocladium
                                   chartarum.          chartarum.
m205............................  Trichophyton        Trichophyton
                                   rubrum.             rubrum.
m207............................  Aspergillus niger.  Aspergillus niger.
m208............................  Chaetomium          Chaetomium
                                   globosum.           globosum.
m209............................  Penicillium         Penicillium
                                   frequentans.        glabrum
                                                       (Penicillium
                                                       frequentans).
m209............................  Stachybotrys        Stachybotrys
                                   chartarum.          chartarum
                                                       (Stachybotrys
                                                       atra).
m210............................  Trichophyton        Trichophyton
                                   mentagrophytes      mentagrophytes
                                   var. goetzii.       var. goetzii.
m211............................  Trichophyton        Trichophyton
                                   mentagrophytes      mentagrophytes
                                   var.                var.
                                   interdigitale.      interdigitale.
m211............................  Oat smut..........  Ustilago avenae.
m212............................  Micropolyspora      Saccharopolyspora
                                   faeni.              rectivirgula
                                                       (Micropolyspora
                                                       faeni).
m212............................  Geotrichum          Geotrichum
                                   candidum.           candidum.
m213............................  Bermuda grass smut  Ustilago
                                                       cynodontis.

[[Page 71805]]

 
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............................  Staphylococcal      Staphylococcus
                                   enterotoxin C       aureus.
                                   (Sta a SEC).
m224............................  Staphylococcal      Staphylococcus
                                   enterotoxin D       aureus.
                                   (Sta a SED).
m226............................  Staphylococcal      Staphylococcus
                                   enterotoxin TSST    aureus.
                                   (Sta a TSST).
m227............................  Malassezia spp.     Malassezia spp.
                                   (Pityrosporum       (Pityrosporum
                                   spp.).              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         Aspergillus
                                   terreus.            terreus.
m310............................  Aspergillus         Aspergillus
                                   nidulans.           nidulans.
m311............................  Aspergillus flavus  Aspergillus
                                                       flavus.
m312............................  Aspergillus         Aspergillus
                                   clavatus.           clavatus.
------------------------------------------------------------------------
                           Epidermal & Animal
------------------------------------------------------------------------
e6..............................  Guinea pig          Cavia porcellus.
                                   epithelium.
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.
e75.............................  Rat serum proteins  Rattus norvegicus,
                                                       Rattus rattus.
e76.............................  Mouse serum         Mus musculus (Mus
                                   proteins.           spp.).
e77.............................  Budgerigar          Melopsittacus
                                   droppings.          undulatus.
e78.............................  Budgerigar          Melopsittacus
                                   feathers.           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,     Rattus norvegicus
                                   serum proteins,     Rattus rattus.
                                   and urine
                                   proteins.
e88.............................  Mouse epithelium,   Mus musculus (Mus
                                   serum proteins,     spp.).
                                   and urine
                                   proteins (mouse).
e89.............................  Turkey feathers...  Meleagris
                                                       gallopavo.
e90.............................  Budgerigar serum    Melopsittacus
                                   proteins,           undulatus.
                                   feathers, and
                                   droppings.
e91.............................  Pigeon serum        Streptopelia
                                   proteins,           roseogrisea,
                                   feathers, and       Psittacidae spp.
                                   droppings.
e92.............................  Parrot serum        Ara spp.
                                   proteins,
                                   feathers, and
                                   droppings.
e93.............................  Pigeon serum        Streptopelia
                                   proteins.           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         Serinus canarius.
                                   droppings.
e201............................  Canary bird         Serinus canarius.
                                   feathers (Canary
                                   feathers).
e202............................  Reindeer            Rangifer tarandus.
                                   epithelium.
e203............................  Mink epithelium...  Mustela spp.

[[Page 71806]]

 
e204............................  Bos d 6...........  Bos domesticus
                                                       (Bos taurus; Bos
                                                       spp.).
e205............................  Horse, serum        Equus caballus
                                   proteins.           (Equus spp.).
e206............................  Rabbit, serum       Oryctolagus
                                   proteins.           cuniculus
                                                       (Oryctolagus
                                                       spp.).
e208............................  Chinchilla          Chinchilla
                                   epithelium.         laniger.
e209............................  Gerbil epithelium.  Meriones
                                                       unguiculatus.
e210............................  Fox epithelium....  Vulpes vulpes.
e211............................  Rabbit, urine       Oryctolagus
                                   proteins.           cuniculus
                                                       (Oryctolagus
                                                       spp.).
e212............................  Swine, urine        Sus scrofa (Sus
                                   proteins.           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      Gallus domesticus
                                   proteins.           (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         Sus scrofa (Sus
                                   albumin (Sus s      scrofa
                                   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.
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     NA.
                                   type.
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.

[[Page 71807]]

 
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.
f162............................  Nectarine.........  Prunus persica
                                                       var. nucipersica.
f163............................  Kohlrabi..........  Brassica oleracea
                                                       var. gongylodes.
f65.............................  Perch.............
f166............................  Leek..............  Allium porrum.
f170............................  Cheese              NA.
                                   (Switzerland)
                                   (Swiss cheese).
f174............................  Fig...............  Ficus carica.
f177............................  Cranberry.........  Vaccinium
                                                       macrocarpon.
f179............................  Raisin............  Vitis spp.
f182............................  Lima bean.........  Phaseolus lunatus.
f198............................  Flaxseed (bruised   Linum
                                   grain).             usitatissimum.
f199............................  Untreated native    Bos domesticus
                                   milk.               (Bos taurus; Bos
                                                       spp.).
f208............................  Lemon.............  Citrus limon.
f209............................  Grapefruit........  Citrus paradisi.
f210............................  Pineapple.........  Ananas comosus.
f211............................  Blackberry........  Rubus fruticosus.
f212............................  Mushroom            Agaricus hortensis
                                   (champignon).       (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      Capsicum annuum.
                                   pepper.
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,      Cucurbita pepo.
                                   pumpkin.
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,          Solanum melongena.
                                   eggplant.
f263............................  Green pepper......  Piper nigrum,
                                                       Capsicum annuum.

[[Page 71808]]

 
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.
f277............................  Dill..............  Anethum
                                                       graveolens.
f278............................  Bay leaf..........  Laurus nobilis.
f279............................  Chili pepper......  Capsicum
                                                       frutescens.
f280............................  Black pepper......  Piper nigrum.
f281............................  Curry (Santa        NA.
                                   Maria).
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,      Passiflora edulis
                                   Maracuja.           (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     Diospyros kaki.
                                   fruit, sharon).
f302............................  Mandarin            Citrus reticulata.
                                   (tangerine,
                                   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,       Olea europaea.
                                   fresh).

[[Page 71809]]

 
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.
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     NA.
                                   Labs.
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/      Ctenocephalides
                                   cat), common flea.  spp.
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      Polistes
                                   wasp.               dominulus.
i78.............................  Fly...............  Musca domestica.
i80.............................  Bumblebee.........  Bombus
                                                       pennsylvanicus.
i201............................  Horse bot fly.....  Gasterophilus
                                                       intestinalis.
i202............................  Grain weevil......  Sitophilus
                                                       granarius.
i203............................  Mediterranean       Ephestia
                                   flour moth.         kuehniella
                                                       (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       Gossypium spp.
                                   fibers.
o3..............................  Cotton (treated)..  Gossypium spp.
o70.............................  Seminal fluid.....  Homo sapiens.
o71.............................  Staphylococcus      Staphylococcus
                                   aureus.             aureus.

[[Page 71810]]

 
o72.............................  Pichia pastoris     Pichia pastoris.
                                   crude extract
                                   customer specific.
o72.............................  Sperm-sediment....  Homo sapiens.
o73.............................  Pichia pastoris     Pichia pastoris.
                                   crude extr.
                                   vector customer
                                   specific.
o74.............................  Pichia pastoris     Pichia pastoris.
                                   with vector
                                   customer specific.
o201............................  Tobacco leaf,       Nicotiana tabacum.
                                   tobacco dust.
o202............................  Artemia salina,     Artemia salina.
                                   fish feed.
o203............................  Tetramin, fish      NA.
                                   feed.
o207............................  Daphnia, fish feed  Daphnia spp.
o211............................  Mealworm..........  Tenebrio molitor.
o212............................  Streptavidin......  Streptomyces
                                                       avidini.
o213............................  MBP (maltose        Escherichia coli.
                                   binding protein).
o214............................  CCD; MUXF3 from     Ananas comosus.
                                   bromelain.
o72.............................  Enterotoxin A (Sta  Staphylococcus
                                   a SEA).             aureus.
o73.............................  Enterotoxin B (Sta  Staphylococcus
                                   a SEB).             aureus.
------------------------------------------------------------------------
                                Parasites
------------------------------------------------------------------------
p1..............................  Ascaris...........  Ascaris suum.
p2..............................  Echinococcus......  Echinococcus
                                                       granulosus.
p3..............................  Schistosoma.......  Schistosoma
                                                       mansoni.
p4..............................  Anisakis (Herring   Anisakis simplex
                                   Worm).              (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        Ovis aries (Ovis
                                   (treated) (wool).   spp.).
k21.............................  Sheep's wool        Ovis aries (Ovis
                                   (Untreated).        spp.).
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      NA.
                                   (Toluene
                                   diisocyanate).
k76.............................  Isocyanate MDI      NA.
                                   (Diphenylmethane
                                   diisocyanate).
k77.............................  Isocyanate HDI      NA.
                                   (Hexamethylen
                                   diisocyanate).
k78.............................  Ethylene oxide....  NA.
k79.............................  Phthalic anhydride  NA.
k80.............................  Formaldehyde/       NA.
                                   Formalin.
k81.............................  Ficus.............  Ficus benjamina
                                                       (Ficus spp.).
k83.............................  Cotton seed.......  Gossypium
                                                       hirsutum.
k84.............................  Sunflower seed....  Helianthus annuus.
k85.............................  Chloramin T.......  NA.
k86.............................  Trimellitic         NA.
                                   anhydride, TMA.
k87.............................  Asp o 21, alpha-    Aspergillus
                                   amylase.            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  Bacillus spp.
                                   1 (Bac l
                                   Subtilisin).
k208............................  Gal d 4, Lysozyme.  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
k209............................  Hexahydrophtalic    NA.
                                   anhydrid.
k210............................  Maleic anhydride..  NA.
k211............................  Methyltetrahydroph  NA.
                                   talic anhydrid.
k212............................  Abachi wood dust..  Triplochiton
                                                       scleroxylon.
k213............................  Pepsin (Sus s       Sus scrofa (Sus
                                   Pepsin).            scrofa
                                                       domesticus; Sus
                                                       spp.).
k213............................  TCPA..............  NA.
k214............................  Bougainvillea.....  Bougainvillea spp.
k225............................  Horse radish        Armoracia
                                   peroxidase (Arm r   rusticana.
                                   HRP).

[[Page 71811]]

 
k226............................  Ascorbate oxidase   Cucurbita pepo.
                                   (Cuc p ascorbate
                                   oxidase).
k301............................  Flour dust........  Triticum spp.
k501............................  Savinase customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k502............................  Lipolase customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k503............................  Termamyl customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k504............................  Clazinase customer  Proprietary
                                   specific.           knowledge of
                                                       customer.
------------------------------------------------------------------------


0
66. In Sec.  866.5910, revise paragraph (b) to read as follows:


Sec.  866.5910  Quality control material for cystic fibrosis nucleic 
acid assays.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Quality Control Material for Cystic 
Fibrosis Nucleic Acid Assays.'' See Sec.  866.1(e) for the availability 
of this guidance document.

PART 868--ANESTHESIOLOGY DEVICES

0
67. The authority citation for part 868 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
68. In Sec.  868.1040, revise paragraph (b) to read as follows:


Sec.  868.1040  Powered algesimeter.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9.

0
69. In Sec.  868.2385, revise paragraph (b) to read as follows:


Sec.  868.2385  Nitrogen dioxide analyzer.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a standalone nitrogen dioxide analyzer and not those that are 
components of nitric oxide delivery systems intended to monitor 
nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  868.9. The special 
control is FDA's ``Guidance Document for Premarket Notification 
Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide 
Analyzer, and Nitrogen Dioxide Analyzer.'' See Sec.  868.1(e) for the 
availability of this guidance document.

0
70. In Sec.  868.2500, revise paragraph (b) to read as follows:


Sec.  868.2500  Cutaneous oxygen (PcO2) monitor.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9. The 
special control is FDA's ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance 
for Industry and FDA.'' See Sec.  868.1(e) for the availability of this 
guidance document.

0
71. In Sec.  868.2550, revise paragraph (b) to read as follows:


Sec.  868.2550  Pneumotachometer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9.

0
72. In Sec.  868.5180, revise paragraph (b) to read as follows:


Sec.  868.5180  Rocking bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9.

0
73. In Sec.  868.6250, revise paragraph (b) to read as follows:


Sec.  868.6250  Portable air compressor.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  868.9.

PART 870--CARDIOVASCULAR DEVICES

0
74. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
75. In Sec.  870.1330, revise paragraph (b) to read as follows:


Sec.  870.1330  Catheter guide wire.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a torque device that is manually operated, non-patient 
contacting, and intended to manipulate non-cerebral vascular guide 
wires, is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
870.9.

0
76. In Sec.  870.1390, revise paragraph (b) to read as follows:


Sec.  870.1390  Trocar.

* * * * *
    (b) Classification. Class II (special controls). Except for trocars 
that are reprocessed for multiple use, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  870.9.

0
77. In Sec.  870.1650, revise paragraph (b) to read as follows:


Sec.  870.1650  Angiographic injector and syringe.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a non-patient contacting balloon inflation syringe intended only 
to inflate/deflate balloon catheters and monitor pressure within the 
balloon, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  870.9.

0
78. In Sec.  870.1875, revise paragraph (b)(2) to read as follows:


Sec.  870.1875  Stethoscope.

* * * * *
    (b) * * *
    (2) Classification. Class II (special controls). The device, when 
it is a lung sound monitor, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  870.9.

[[Page 71812]]


0
79. In Sec.  870.2675, revise paragraph (b) to read as follows:


Sec.  870.2675  Oscillometer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

0
80. In Sec.  870.2770, revise paragraph (b) to read as follows:


Sec.  870.2770  Impedance plethysmograph.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a body composition analyzer which is not intended to diagnose or 
treat any medical condition, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  870.9.

0
81. In Sec.  870.4280, revise paragraph (b) to read as follows:


Sec.  870.4280  Cardiopulmonary prebypass filter.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

0
82. In Sec.  870.4290, revise paragraph (b) to read as follows:


Sec.  870.4290  Cardiopulmonary bypass adaptor, stopcock, manifold, or 
fitting.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

0
83. In Sec.  870.4340, revise paragraph (b) to read as follows:


Sec.  870.4340  Cardiopulmonary bypass level sensing monitor and/or 
control.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

0
84. In Sec.  870.4400, revise paragraph (b) to read as follows:


Sec.  870.4400  Cardiopulmonary bypass blood reservoir.

* * * * *
    (b) Classification. Class II (special controls), except that a 
reservoir that contains a defoamer or filter is classified into the 
same class as the defoamer or filter. The device, when it is a 
cardiopulmonary bypass blood reservoir that does not contain defoamers 
or blood filters, is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec.  870.9.

0
85. In Sec.  870.4420, revise paragraph (b) to read as follows:


Sec.  870.4420  Cardiopulmonary bypass cardiotomy return sucker.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

0
86. In Sec.  870.4430, revise paragraph (b) to read as follows:


Sec.  870.4430  Cardiopulmonary bypass intracardiac suction control.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.

PART 872--DENTAL DEVICES

0
87. The authority citation for part 872 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
88. In Sec.  872.1720, revise paragraph (b) to read as follows:


Sec.  872.1720  Pulp tester.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9.

0
89. In Sec.  872.3260, revise paragraph (b) to read as follows:


Sec.  872.3260  Cavity varnish.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an external cleaning solution, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  872.9.

0
90. In Sec.  872.3300, revise paragraph (b) to read as follows:


Sec.  872.3300  Hydrophilic resin coating for dentures.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9.

0
91. In Sec.  872.3540, revise paragraph (b)(2) introductory text to 
read as follows:


Sec.  872.3540  OTC denture cushion or pad.

* * * * *
    (b) * * *
    (2) Class II (special controls) if the OTC denture cushion or pad 
is made of a material other than wax-impregnated cotton cloth or if the 
intended use of the device differs from that described in paragraph 
(b)(1) of this section. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  872.9. The special controls for 
this device are FDA's:
* * * * *

0
92. In Sec.  872.3560, revise paragraph (b) introductory text to read 
as follows:


Sec.  872.3560  OTC denture reliner.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. The 
special controls for this device are FDA's:
* * * * *

0
93. In Sec.  872.3590, revise paragraph (b) to read as follows:


Sec.  872.3590  Preformed plastic denture tooth.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9.

0
94. In Sec.  872.3600, revise paragraph (b) introductory text to read 
as follows:


Sec.  872.3600  Partially fabricated denture kit.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9. The 
special controls for this device are FDA's:
* * * * *

0
95. In Sec.  872.3890, revise paragraph (b) to read as follows:


Sec.  872.3890  Endodontic stabilizing splint.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9.

0
96. In Sec.  872.5550, revise paragraph (b)(2) to read as follows:


Sec.  872.5550  Teething ring.

* * * * *
    (b) * * *

[[Page 71813]]

    (2) Class II (special controls) if the teething ring contains a 
fluid, such as water. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  872.9.

0
97. In Sec.  872.6770, revise paragraph (b) to read as follows:


Sec.  872.6770  Cartridge syringe.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  872.9.

PART 874--EAR, NOSE, AND THROAT DEVICES

0
98. The authority citation for part 874 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
99. In Sec.  874.1090, revise paragraph (b) to read as follows:


Sec.  874.1090  Auditory impedance tester.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a tympanometer or auditory impedance tester that complies with 
FDA-recognized consensus standard ANSI S3.39, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  874.9.

0
100. In Sec.  874.1120, revise paragraph (b) to read as follows:


Sec.  874.1120  Electronic noise generator for audiometric testing.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
101. In Sec.  874.1325, revise paragraph (b) to read as follows:


Sec.  874.1325  Electroglottograph.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
102. In Sec.  874.3310, revise paragraph (b) to read as follows:


Sec.  874.3310  Hearing aid calibrator and analysis system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
103. In Sec.  874.3320, revise paragraph (b) to read as follows:


Sec.  874.3320  Group hearing aid or group auditory trainer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
104. In Sec.  874.3330, revise paragraph (b) to read as follows:


Sec.  874.3330  Master hearing aid.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
105. In Sec.  874.3430, revise paragraph (b) to read as follows:


Sec.  874.3430  Middle ear mold.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  874.9.

0
106. In Sec.  874.3730, revise paragraph (b) to read as follows:


Sec.  874.3730  Laryngeal prosthesis (Taub design).

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a voice amplification device, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
107. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
108. In Sec.  876.1500, revise paragraph (b)(1) to read as follows:


Sec.  876.1500  Endoscope and accessories.

* * * * *
    (b) * * *
    (1) Class II (special controls). The device, when it is an 
endoscope disinfectant basin, which consists solely of a container that 
holds disinfectant and endoscopes and accessories; an endoscopic 
magnetic retriever intended for single use; sterile scissors for 
cystoscope intended for single use; a disposable, non-powered 
endoscopic grasping/cutting instrument intended for single use; a 
diagnostic incandescent light source; a fiberoptic photographic light 
source; a routine fiberoptic light source; an endoscopic sponge 
carrier; a xenon arc endoscope light source; an endoscope transformer; 
an LED light source; or a gastroenterology-urology endoscopic 
guidewire, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  876.9.
* * * * *

0
109. In Sec.  876.4020, revise paragraph (b) to read as follows:


Sec.  876.4020  Fiberoptic light ureteral catheter.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
110. In Sec.  876.4270, revise paragraph (b) to read as follows:


Sec.  876.4270  Colostomy rod.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
111. In Sec.  876.4400, revise paragraph (b) to read as follows:


Sec.  876.4400  Hemorrhoidal ligator.

* * * * *
    (b) Classification. Class II (special controls). Except for a 
hemostatic metal clip intended for use in the gastrointestinal tract, 
the device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  876.9.

0
112. In Sec.  876.4500, revise paragraph (b) to read as follows:


Sec.  876.4500  Mechanical lithotriptor.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a biliary mechanical lithotripter, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  876.9.

0
113. In Sec.  876.4770, revise paragraph (b) to read as follows:


Sec.  876.4770  Urethrotome.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

[[Page 71814]]


0
114. In Sec.  876.5010, revise paragraph (b) to read as follows:


Sec.  876.5010  Biliary catheter and accessories.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a bile collecting bag or a surgical biliary catheter that does 
not include a balloon component, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  876.9.

0
115. In Sec.  876.5025, revise paragraph (b) introductory text to read 
as follows:


Sec.  876.5025  Vibrator for climax control of premature ejaculation.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9. The 
special controls for this device are:
* * * * *

0
116. In Sec.  876.5160, revise the section heading and paragraph (b) to 
read as follows:


Sec.  876.5160  Urological clamp.

* * * * *
    (b) Classification. Class I (general controls). Except when 
intended for internal use, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  876.9.

0
117. In Sec.  876.5365, revise paragraph (b) to read as follows:


Sec.  876.5365  Esophageal dilator.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
118. In Sec.  876.5520, revise paragraph (b)(1) to read as follows:


Sec.  876.5520  Urethral dilator.

* * * * *
    (b) * * *
    (1) Class II (special controls). Except when it is a mechanical 
urethral dilator, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  876.9.
* * * * *

0
119. In Sec.  876.5630, revise paragraph (b) to read as follows:


Sec.  876.5630  Peritoneal dialysis system and accessories.

* * * * *
    (b) Classification. Class II (special controls). The following 
accessories are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  876.9: A catheter finger grip that is non-patient contacting and 
intended for single use with a peritoneal catheter; a continuous 
ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that 
does not include weigh scales.

0
120. In Sec.  876.5665, revise paragraph (b) to read as follows:


Sec.  876.5665  Water purification system for hemodialysis.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a water purification subsystem disinfectant, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  876.9.

0
121. In Sec.  876.5895, revise paragraph (b) to read as follows:


Sec.  876.5895  Ostomy irrigator.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
122. In Sec.  876.5980, revise paragraph (b)(1) to read as follows:


Sec.  876.5980  Gastrointestinal tube and accessories.

* * * * *
    (b) * * *
    (1) Class II (special controls). The barium enema retention 
catheter and tip with or without a bag that is a gastrointestinal tube 
and accessory or a gastronomy tube holder accessory is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  876.9.
* * * * *

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
123. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
124. In Sec.  878.4370, revise paragraph (b) to read as follows:


Sec.  878.4370  Surgical drape and drape accessories.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an ear, nose, and throat surgical drape, a latex sheet drape with 
self-retaining finger cot, a disposable urological drape, a Kelly pad, 
an ophthalmic patient drape, an ophthalmic microscope drape, an 
internal drape retention ring (wound protector), or a surgical drape 
that does not include an antimicrobial agent, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  878.9.

0
125. In Sec.  878.4495, revise paragraph (b) to read as follows:


Sec.  878.4495  Stainless steel suture.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a steel monofilament suture that is uncoated and does not 
incorporate barbs, is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec.  878.9. The special control for this device is FDA's ``Class II 
Special Controls Guidance Document: Surgical Sutures; Guidance for 
Industry and FDA.'' See Sec.  878.1(e) for the availability of this 
guidance document.

0
126. In Sec.  878.4580, revise paragraph (b) to read as follows:


Sec.  878.4580  Surgical lamp.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an operating room lamp, a surgical instrument light, a surgical 
floor standing light, an endoscopic surgical light, a surgical light 
connector, a ceiling mounted surgical light, a surgical light carrier, 
surgical light accessories, a surgical lamp, a remote illuminator, or 
an incandescent surgical lamp, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  878.9.

0
127. In Sec.  878.5070, revise paragraph (b) to read as follows:


Sec.  878.5070  Air-handling apparatus for a surgical operating room.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an air handling bench apparatus, an air handling room apparatus, 
or an air handling enclosure apparatus, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
128. The authority citation for part 880 continues to read as follows:


[[Page 71815]]


    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
129. In Sec.  880.5580, revise paragraph (b) introductory text to read 
as follows:


Sec.  880.5580  Acupuncture needle.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an acupuncture point locator or a single use acupuncture needle, 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec.  880.9. 
Acupuncture needles must comply with the following special controls:
* * * * *

0
130. In Sec.  880.5680, revise paragraph (b) to read as follows:


Sec.  880.5680  Pediatric position holder.

* * * * *
    (b) Classification. Class I (general controls). Except when the 
device is an infant positioner for prescription use in highly monitored 
settings or an infant sleep position holder, it is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  880.9. The device is exempt 
from the good manufacturing practice regulation in part 820 of this 
chapter, with the exception of Sec.  820.180, with respect to general 
requirements concerning records, and Sec.  820.198, with respect to 
complaint files.

0
131. In Sec.  880.5780, revise paragraph (a)(2) to read as follows:


Sec.  880.5780  Medical support stocking.

    (a) * * *
    (2) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  880.9.
* * * * *

0
132. In Sec.  880.6250, revise paragraph (b) to read as follows:


Sec.  880.6250  Non-powdered patient examination glove.

* * * * *
    (b) Classification. Class I (general controls). The device, when it 
is a finger cot, is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec.  880.9.

0
133. In Sec.  880.6375, revise paragraph (b) to read as follows:


Sec.  880.6375  Patient lubricant.

* * * * *
    (b) Classification. Class I (general controls). Except when the 
device is a vaginal patient lubricant or an oral lubricant, it is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  880.9.

0
134. In Sec.  880.6760, revise paragraph (b) to read as follows:


Sec.  880.6760  Protective restraint.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  880.9.

PART 882--NEUROLOGICAL DEVICES

0
135. The authority citation for part 882 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
136. In Sec.  882.1020, revise paragraph (b) to read as follows:


Sec.  882.1020  Rigidity analyzer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
137. In Sec.  882.1030, revise paragraph (b) to read as follows:


Sec.  882.1030  Ataxiagraph.

* * * * *
    (b) Classification. Class I (general controls). Except when the 
device is intended to provide an interpretation or a clinical 
implication of the measurement, it is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  882.9.

0
138. In Sec.  882.1470, revise paragraph (b) introductory text to read 
as follows:


Sec.  882.1470  Computerized cognitive assessment aid.

* * * * *
    (b) Classification. Class II (special controls). Except when the 
computerized cognitive assessment aid is intended for diagnostic 
assessment of specific diseases or conditions and relies on inputs from 
visual cues, auditory cues, and/or functional use of the hand, the 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
882.9. The special control(s) for this device are:
* * * * *

0
139. In Sec.  882.1540, revise paragraph (b) to read as follows:


Sec.  882.1540  Galvanic skin response measurement device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
140. In Sec.  882.1560, revise paragraph (b) to read as follows:


Sec.  882.1560  Skin potential measurement device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
141. In Sec.  882.1855, revise paragraph (b) to read as follows:


Sec.  882.1855  Electroencephalogram (EEG) telemetry system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
142. In Sec.  882.4060, revise paragraph (b) to read as follows:


Sec.  882.4060  Ventricular cannula.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
143. In Sec.  882.4545, revise paragraph (b) to read as follows:


Sec.  882.4545  Shunt system implantation instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9.

0
144. In Sec.  882.5895, revise paragraph (b) introductory text to read 
as follows:


Sec.  882.5895  Vibratory counter-stimulation device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  882.9. The 
special controls for this device are:
* * * * *

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
145. The authority citation for part 884 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


[[Page 71816]]



0
146. In Sec.  884.1630, revise paragraph (b) to read as follows:


Sec.  884.1630  Colposcope.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a standard colposcope (or colpomicroscope) that uses only a white 
light source, does not use filters other than a green filter, does not 
include image analysis software, and is not smartphone-based, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  884.9.

0
147. In Sec.  884.2990, revise paragraph (b) to read as follows:


Sec.  884.2990  Breast lesion documentation system.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a breast examination recording sheet, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  884.9. The special control 
is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Breast Lesion Documentation System.'' See Sec.  884.1(e) for 
the availability of this guidance document.

0
148. In Sec.  884.3200, revise paragraph (b) to read as follows:


Sec.  884.3200  Cervical drain.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9.

0
149. In Sec.  884.4400, revise paragraph (b) to read as follows:


Sec.  884.4400  Obstetric forceps.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9.

0
150. In Sec.  884.4530, revise paragraph (b)(1) to read as follows:


Sec.  884.4530  Obstetric-gynecologic specialized manual instrument.

* * * * *
    (b) * * *
    (1) Class II (special controls). The device, when it is an 
umbilical clamp with or without a cutter, a uterine tenaculum which is 
sterile and does not use suction and is intended for single use, a 
nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec.  884.9.
* * * * *

0
151. In Sec.  884.4900, revise paragraph (b) to read as follows:


Sec.  884.4900  Obstetric table and accessories.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9.

0
152. In Sec.  884.5200, revise paragraph (b) introductory text to read 
as follows:


Sec.  884.5200  Hemorrhoid prevention pressure wedge.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9. The 
special controls for this device are:
* * * * *

0
153. In Sec.  884.5390, revise paragraph (b) to read as follows:


Sec.  884.5390  Perineal heater.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9.

0
154. In Sec.  884.5400, revise paragraph (b) to read as follows:


Sec.  884.5400  Menstrual cup.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9.

0
155. In Sec.  884.5425, revise paragraph (b)(2) to read as follows:


Sec.  884.5425  Scented or scented deodorized menstrual pad.

* * * * *
    (b) * * *
    (2) Class II (special controls) for scented or scented deodorized 
menstrual pads made of materials not described in paragraph (b)(1). The 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
884.9.

0
156. In Sec.  884.5435, revise paragraph (b) to read as follows:


Sec.  884.5435  Unscented menstrual pad.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  884.9 only when 
the device is made of common cellulosic and synthetic material with an 
established safety profile.

0
157. In Sec.  884.6120, revise paragraph (b) to read as follows:


Sec.  884.6120  Assisted reproduction accessories.

* * * * *
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing). The 
device, when it is a simple embryo incubator with only temperature, 
gas, and humidity control; a syringe pump; a collection tube warmer; a 
dish/plate/microscope stage warmer; or a controlled-rate 
cryopreservation freezer, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  884.9.

0
158. In Sec.  884.6130, revise paragraph (b) to read as follows:


Sec.  884.6130  Assisted reproduction microtools.

* * * * *
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, and clinical testing). The 
device, when the assisted reproduction microtools (pipettes) are 
manufactured from glass, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  884.9.

0
159. In Sec.  884.6150, revise paragraph (b) to read as follows:


Sec.  884.6150  Assisted reproduction micromanipulators and 
microinjectors.

* * * * *
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing). The 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
884.9.

0
160. In Sec.  884.6160, revise paragraph (b) to read as follows:


Sec.  884.6160  Assisted reproduction labware.

* * * * *
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, and clinical testing). The 
device, when

[[Page 71817]]

it is a dish or plate intended for general assisted reproduction 
technology procedures, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  884.9.

PART 886--OPHTHALMIC DEVICES

0
161. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
162. In Sec.  886.1120, revise paragraph (b) to read as follows:


Sec.  886.1120  Ophthalmic camera.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a photorefractor or a general-use ophthalmic camera, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  886.9.

0
163. In Sec.  886.1250, revise paragraph (b) to read as follows:


Sec.  886.1250  Euthyscope.

* * * * *
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  886.9.

0
164. In Sec.  886.1570, revise paragraph (b) to read as follows:


Sec.  886.1570  Ophthalmoscope.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or 
a hand-held ophthalmoscope replacement battery, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  886.9.

0
165. In Sec.  886.1780, revise paragraph (b)(1) to read as follows:


Sec.  886.1780  Retinoscope.

* * * * *
    (b) * * *
    (1) Class II (special controls) for the AC-powered device. The 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec.  
886.9.
* * * * *

0
166. In Sec.  886.1850, revise paragraph (b) to read as follows:


Sec.  886.1850  AC-powered slitlamp biomicroscope.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is intended only for the visual examination of the anterior segment 
of the eye, is classified as Group 1 per FDA-recognized consensus 
standard ANSI Z80.36, does not provide any quantitative output, and is 
not intended for screening or automated diagnostic indications, is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

0
167. In Sec.  886.1945, revise paragraph (b) to read as follows:


Sec.  886.1945  Transilluminator.

* * * * *
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  886.9.

0
168. In Sec.  886.3320, revise paragraph (b) to read as follows:


Sec.  886.3320  Eye sphere implant.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an ocular peg which is supplied sterile only, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  886.9.

0
169. In Sec.  886.4070, revise paragraph (b) to read as follows:


Sec.  886.4070  Powered corneal burr.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

0
170. In Sec.  886.4150, revise paragraph (b) to read as follows:


Sec.  886.4150  Vitreous aspiration and cutting instrument.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is phacofragmentation unit replacement tubing, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  886.9.

0
171. In Sec.  886.4250, revise paragraph (b) to read as follows:


Sec.  886.4250  Ophthalmic electrolysis unit.

* * * * *
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  886.9.

0
172. In Sec.  886.4335, revise paragraph (b) to read as follows:


Sec.  886.4335  Operating headlamp.

* * * * *
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  886.9.

0
173. In Sec.  886.4400, revise paragraph (b) to read as follows:


Sec.  886.4400  Electronic metal locator.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

0
174. In Sec.  886.4440, revise paragraph (b) to read as follows:


Sec.  886.4440  AC-powered magnet.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

0
175. In Sec.  886.4790, revise paragraph (b) to read as follows:


Sec.  886.4790  Ophthalmic sponge.

* * * * *

[[Page 71818]]

    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

PART 888--ORTHOPEDIC DEVICES

0
176. The authority citation for part 888 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
177. In Sec.  888.1240, revise paragraph (b) to read as follows:


Sec.  888.1240  AC-powered dynamometer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  888.9.

0
178. In Sec.  888.4580, revise paragraph (b) to read as follows:


Sec.  888.4580  Sonic surgical instrument and accessories/attachments.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  888.9.

PART 890--PHYSICAL MEDICINE DEVICES

0
179. The authority citation for part 890 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
180. In Sec.  890.1450, revise paragraph (b) to read as follows:


Sec.  890.1450  Powered reflex hammer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  890.9.

0
181. In Sec.  890.5100, revise paragraph (b) to read as follows:


Sec.  890.5100  Immersion hydrobath.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a hydromassage bath or a powered sitz bath, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  890.9.

0
182. In Sec.  890.5110, revise paragraph (b) to read as follows:


Sec.  890.5110  Paraffin bath.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  890.9.

0
183. In Sec.  890.5250, revise paragraph (b) to read as follows:


Sec.  890.5250  Moist steam cabinet.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  890.9.

0
184. In Sec.  890.5360, revise paragraph (b) to read as follows:


Sec.  890.5360  Measuring exercise equipment.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is a measuring exerciser, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  890.9.

0
185. In Sec.  890.5500, revise paragraph (b) to read as follows:


Sec.  890.5500  Infrared lamp.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is an infrared therapeutic heating lamp, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  890.9.

0
186. In Sec.  890.5575, revise paragraph (b) to read as follows:


Sec.  890.5575  Powered external limb overload warning device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  890.9.

PART 892--RADIOLOGY DEVICES

0
187. The authority citation for part 892 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
188. In Sec.  892.1000, revise paragraph (b) to read as follows:


Sec.  892.1000  Magnetic resonance diagnostic device.

* * * * *
    (b) Classification. Class II (special controls). A magnetic 
resonance imaging disposable kit intended for use with a magnetic 
resonance diagnostic device only is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  892.9.

0
189. In Sec.  892.1560, revise paragraph (b) to read as follows:


Sec.  892.1560  Ultrasonic pulsed echo imaging system.

* * * * *
    (b) Classification. Class II (special controls). A biopsy needle 
guide kit intended for use with an ultrasonic pulsed echo imaging 
system only is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  892.9.

0
190. In Sec.  892.1610, revise paragraph (b) to read as follows:


Sec.  892.1610  Diagnostic x-ray beam-limiting device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
191. In Sec.  892.1650, revise paragraph (b) to read as follows:


Sec.  892.1650  Image-intensified fluoroscopic x-ray system.

* * * * *
    (b) Classification. Class II (special controls). An anthrogram tray 
or radiology dental tray intended for use with an image-intensified 
fluoroscopic x-ray system only is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec.  892.9. In addition, when intended 
as an accessory to the device described in paragraph (a) of this 
section, the fluoroscopic compression device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  892.9.

0
192. In Sec.  892.1670, revise paragraph (b) to read as follows:


Sec.  892.1670  Spot-film device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
193. In Sec.  892.1680, revise paragraph (b) to read as follows:


Sec.  892.1680  Stationary x-ray system.

* * * * *
    (b) Classification. Class II (special controls). A radiographic 
contrast tray or radiology diagnostic kit intended for use with a 
stationary x-ray system only is exempt from the premarket notification 
procedures in subpart E of

[[Page 71819]]

part 807 of this chapter subject to the limitations in Sec.  892.9.

0
194. In Sec.  892.1730, revise paragraph (b) to read as follows:


Sec.  892.1730  Photofluorographic x-ray system.

* * * * *
    (b) Classification. Class II (special controls). A discography kit 
intended for use with a photofluorographic x-ray system only is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  892.9.

0
195. In Sec.  892.1820, revise paragraph (b) to read as follows:


Sec.  892.1820  Pneumoencephalographic chair.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
196. In Sec.  892.1850, revise paragraph (b) to read as follows:


Sec.  892.1850  Radiographic film cassette.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
197. In Sec.  892.1860, revise paragraph (b) to read as follows:


Sec.  892.1860  Radiographic film/cassette changer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
198. In Sec.  892.1870, revise paragraph (b) to read as follows:


Sec.  892.1870  Radiographic film/cassette changer programmer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
199. In Sec.  892.1900, revise paragraph (b) to read as follows:


Sec.  892.1900  Automatic radiographic film processor.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

0
200. In Sec.  892.2030, revise paragraph (b) to read as follows:


Sec.  892.2030  Medical image digitizer.

* * * * *
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std.). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  892.9.

0
201. In Sec.  892.2040, revise paragraph (b) to read as follows:


Sec.  892.2040  Medical image hardcopy device.

* * * * *
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture 
and Television Engineers (SMPTE) Test Pattern). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  892.9.

0
202. In Sec.  892.5730, revise paragraph (b) to read as follows:


Sec.  892.5730  Radionuclide brachytherapy source.

* * * * *
    (b) Classification. Class II (special controls). A prostate seeding 
kit intended for use with a radionuclide brachytherapy source only is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  892.9.

    Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27394 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P


