
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67313-67314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27817]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2015-N-3392]


Medical Devices; Immunology and Microbiology Devices; 
Classification of Gastrointestinal Microorganism Multiplex Nucleic 
Acid-Based Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying a 
gastrointestinal microorganism multiplex nucleic acid-based assay into 
class II (special controls). The Agency is classifying the device into 
class II (special controls) in order to provide a reasonable assurance 
of safety and effectiveness of the device.

DATES: This order is effective November 2, 2015. The classification was 
applicable January 14, 2013.

FOR FURTHER INFORMATION CONTACT: Andrew Grove, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on January 03, 2013 automatically classifying the xTAG[supreg] 
Gastrointestinal Pathogen Panel (GPP) in class III, because it was not 
substantially equivalent to a device that was introduced or delivered 
for introduction into interstate commerce for commercial distribution 
before May 28, 1976, nor to a device that was subsequently reclassified 
into class I or class II. On January 10, 2013, Luminex Molecular 
Diagnostics, submitted a request for de novo classification of the 
xTAG[supreg] GPP under section 513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request for de novo classification in order to classify the device 
under the criteria for classification set forth in section 513(a)(1) of 
the FD&C Act. FDA classifies devices into class II if general controls 
by themselves are insufficient to provide reasonable assurance of 
safety and effectiveness, but there is sufficient information to 
establish special controls to provide reasonable assurance of the 
safety and effectiveness of the device for its intended use. After 
review of the information submitted in the request, FDA determined that 
the device can be classified into class II with the establishment of 
special controls. FDA believes these special controls will provide 
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on January 14, 2013, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 866.3990 (Sec.  
866.3990).
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a gastrointestinal microorganism multiplex nucleic acid-
based assay will need to comply with the special controls named in this 
final administrative order.
    The device is assigned the generic name gastrointestinal 
microorganism multiplex nucleic acid-based assay, and it is identified 
as a qualitative in vitro diagnostic device intended to simultaneously 
detect and identify multiple gastrointestinal microbial nucleic acids 
extracted from human stool specimens. The device detects specific 
nucleic acid sequences for organism identification as well as for 
determining the presence of toxin genes. The detection and 
identification of a specific gastrointestinal microbial nucleic acid 
from individuals exhibiting signs and symptoms of gastrointestinal 
infection aids in the diagnosis of gastrointestinal infection when used 
in conjunction with clinical evaluation and other laboratory findings. 
A gastrointestinal microorganism multiplex nucleic acid-based assay 
also aids in the detection and identification of acute gastroenteritis 
in the context of outbreaks.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks 
in table 1:

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           Table 1--Identified Risks and Required Mitigations
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            Identified risks                   Mitigation measures
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Failure of the device to detect and      The FDA document entitled
 identify a targeted organism when such   ``Class II Special Controls
 organism is present in the specimen      Guideline: Gastrointestinal
 (i.e., false negative result for         Microorganism Multiplex
 presence of organism).                   Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements, performance
                                          studies, and labeling.
Detection of the targeted microorganism  The FDA document entitled
 when such organism is not present in     ``Class II Special Controls
 the specimen (i.e., false positive       Guideline: Gastrointestinal
 result for presence of organism).        Microorganism Multiplex
                                          Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements, performance
                                          studies, and labeling.
Failure to correctly interpret test      The FDA document entitled
 results.                                 ``Class II Special Controls
                                          Guideline: Gastrointestinal
                                          Microorganism Multiplex
                                          Nucleic Acid-Based Assays for
                                          Detection and Identification
                                          of Microorganisms and Toxin
                                          Genes from Human Stool
                                          Specimens,'' which addresses
                                          this risk through: Specific
                                          device description
                                          requirements and labeling.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls 
guideline entitled ``Class II Special Controls Guideline: 
Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for 
Detection and Identification of Microorganisms and Toxin Genes from 
Human Stool Specimens'' are necessary, in addition to general controls, 
to mitigate the risks to health described in table 1.

II. Premarket Notification

    A gastrointestinal microorganism multiplex nucleic acid-based assay 
is a prescription device. Section 510(m) of the FD&C Act provides that 
FDA may exempt a class II device from the premarket notification 
requirements under section 510(k) of the FD&C Act if FDA determines 
that premarket notification is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. For this type 
of device, FDA has determined that premarket notification is necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. Therefore, this type of device is not exempt from premarket 
notification requirements. Persons who intend to market this type of 
device must submit to FDA a premarket notification, prior to marketing 
the device, which contains information about the gastrointestinal 
microorganism multiplex nucleic acid-based assay they intend to market.

III. Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of 
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.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. 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. 3501-3520). The collections of 
information in 21 CFR part 807, subpart E, regarding premarket 
notification submissions have been approved under OMB control number 
0910-0120; the collections of information in 21 CFR part 820 regarding 
quality systems have been approved under OMB control number 0910-0073; 
and the collections of information in 21 CFR parts 801 and 809 
regarding labeling have been approved under OMB control number 0910-
0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

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

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


0
2. Add Sec.  866.3990 to subpart D to read as follows:


Sec.  866.3990  Gastrointestinal microorganism multiplex nucleic acid-
based assay.

    (a) Identification. A gastrointestinal microorganism multiplex 
nucleic acid-based assay is a qualitative in vitro diagnostic device 
intended to simultaneously detect and identify multiple 
gastrointestinal microbial nucleic acids extracted from human stool 
specimens. The device detects specific nucleic acid sequences for 
organism identification as well as for determining the presence of 
toxin genes. The detection and identification of a specific 
gastrointestinal microbial nucleic acid from individuals exhibiting 
signs and symptoms of gastrointestinal infection aids in the diagnosis 
of gastrointestinal infection when used in conjunction with clinical 
evaluation and other laboratory findings. A gastrointestinal 
microorganism multiplex nucleic acid-based assay also aids in the 
detection and identification of acute gastroenteritis in the context of 
outbreaks.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's guideline document entitled: ``Class II 
Special Controls Guideline: Gastrointestinal Microorganism Multiplex 
Nucleic Acid-Based Assays for Detection and Identification of 
Microorganisms and Toxin Genes from Human Stool Specimens.'' For 
availability of the guideline document, see Sec.  866.1(e).

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27817 Filed 10-30-15; 8:45 am]
 BILLING CODE 4164-01-P


