The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real Time PCR Instrument in conjunction with clinical and epidemiological information:

For determination of the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]), and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture:
To provide epidemiologic information for surveillance of circulating influenza viruses.

Device Description

The Influenza A Subtyping Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in real-time RT-PCR (rRT-PCR) assays on the ABI 7500 Fast Dx Real-Time PCR Instrument. The Influenza A Subtyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes to be used in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients presenting with influenza-like illness (ILI).

The Influenza A Subtyping Kit is based on technology which is used in many molecular diagnostic assays. rRT-PCR assays are one-tube assays that first reverse-transcribe specific regions of RNA into cDNA copies. The cDNA then serves as a template for a polymerase chain reaction that utilizes a thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals to a specific internal target sequence located between the target loci of the forward and reverse primers. During the extension phase of the 5' nuclease activity of Tag polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dve to separate from the quencher dye, and generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. Amplification of targets is reflected by logarithmic increase in fluorescence over time in comparison to the background signal.

AI/ML Overview

This 510(k) submission, K140851, is a "Special 510(k)" for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit. The documentation states that the changes proposed are "for labeling purposes only and will not alter the technological attributes of the device." Therefore, this submission provides a comparison to the predicate device (K132508) based on intended use, specimen types, technology, required instrumentation, organism detected, and nucleic acid extraction, rather than new performance data. No new studies were conducted to re-establish acceptance criteria or device performance, as the device itself is considered unchanged from the predicate.

Here's a breakdown of the requested information based on what's available in the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) for a labeling change and explicitly states "will not alter the technological attributes of the device," no new performance studies were conducted to establish new acceptance criteria or reported device performance for K140851. The performance characteristics are assumed to be identical to the predicate device (K132508).

The table provided in the submission (Table 1: Device Comparison) outlines the differences in the intended use language and organism detection specificity between the predicate device (K132508) and the new Influenza A Subtyping Kit, which represents a subset of the predicate's capabilities.

Feature	Predicate Device (K132508) Performance/Specification	Proposed Device (K140851, Influenza A Subtyping Kit) Performance/Specification
Intended Use	For qualitative detection of influenza virus type A or B... For determination of the subtype of seasonal human influenza A virus... For the determination of the genetic lineage of human influenza B viruses... For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5 (Asian Lineage)... To provide epidemiologic information for surveillance.	For determination of the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09... To provide epidemiologic information for surveillance.
Specimen Types	Upper and lower respiratory tract specimens; only upper respiratory specimens for influenza B genetic lineage determination.	Upper and lower respiratory tract specimens.
Technology	Real-time RT-PCR	Same (Real-time RT-PCR)
Instrumentation	Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4	Same
Organism Detected	Universal influenza A viruses (animal and human), Swine-origin influenza A viruses, Influenza B viruses, Influenza A subtypes: seasonal A/H1, A/H3, A/H1pdm09, and A/H5, Influenza B/Yamagata and B/Victoria lineages.	Universal influenza A viruses (animal and human), Swine-origin influenza A viruses, Influenza A subtypes: seasonal A/H1, A/H3, A/H1pdm09.
Nucleic Acid Extraction	Yes	Same (Yes)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No new test set data is presented for this Special 510(k) as it is a labeling modification. The original performance characteristics were established during a season when seasonal influenza viruses A/H1 and A/H3 were predominant, and during a season when A/H1pdm09 was predominant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new performance studies were conducted. The ground truth for the predicate device's performance would have been established through a combination of methods, likely including viral culture, sequencing, and/or other validated molecular methods, but this information is not provided in the current document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new performance studies were conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a molecular diagnostic assay, not an imaging device requiring human reader interpretation in an MRMC study and does not involve AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a standalone diagnostic kit that produces qualitative results (presence/absence and subtyping of specific influenza viruses). The performance information presented for the predicate device would have been standalone performance. The current submission, being a labeling change, does not include new standalone performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in this document. For the predicate device, ground truth for influenza detection and subtyping would typically be established by viral culture isolation and identification, and/or by sequencing, or other highly validated molecular diagnostic methods.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, and no new training set data is discussed.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning/AI device.

Summary

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K140851

New Special 510(k) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel. Influenza A Subtyping Kit

8. 510(k) Summarv

CDC hereby submits this Special 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter

Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA 30333 Establishment Registration: 1050190

Contact Person

CDR Yon Yu, Pharm.D. Acting Associate Director for Regulatory Affairs Office of the Director National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention 1600 Clifton Road. NE. MS C-18 Atlanta, GA 30333 (404) 639-3046 (office) (404) 639-1275 (fax) fkb8@cdc.gov

Proprietary Name

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Common or Usual Name

Influenza A Subtyping Kit

Regulatory Information

Classification Regulation Section: 866.3980- Respiratory viral panel multiplex nucleic acid assay Classification: Class II Classification Product Code: OEP Subsequent Product Codes: NSU, OZE, OQW Panel: Microbiology

Predicate Device

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (K132508)

Device Description

APR 2 5 2014

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CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

thermocyclic heating and cooling of the reaction to logarithmically amplify a specific region of DNA. The probe anneals to a specific internal target sequence located between the target loci of the forward and reverse primers. During the extension phase of the 5' nuclease activity of Tag polymerase degrades any probe molecules hybridized to amplified target sequence, causing the reporter dve to separate from the quencher dye, and generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is monitored at each PCR cycle. Amplification of targets is reflected by logarithmic increase in fluorescence over time in comparison to the background signal.

Intended Use

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument in conjunction with clinical and epidemiological information:

. For determination of the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]), and lower respiratory tract specimens (including bronchoalveolar lavage /BAL], bronchial wash [BW], tracheal aspirate
[TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture.
. To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1odm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3+ facility is available to receive and culture specimens.

All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.

Technological Characteristics

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The changes proposed to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel subject to this Special 510(k) are for labeling purposes only and will not alter the technological attributes of the device.

Substantial Equivalence Comparison

The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (K132508) will serve as the predicate for the intended change. Please see Table 1 for a detailed comparison.

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New Special 510(k)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

	Table 1: Device Comparison
Intended Use	CDC Human Influenza Virus Real-time PCR Diagnostic Panel (K132508)The CDC Human Influenza Virus Real-Time PCR Diagnostic Panel is intended for use in Real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information: For qualitative detection of influenza virus type A or B from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower respiratory tract specimens (including bronchoalveolar lavages, bronchial washes, tracheal aspirates, sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture; For determination of the subtype of seasonal human influenza A virus as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower respiratory tract specimens (including bronchoalveolar lavages, bronchial washes, tracheal aspirates, sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture; For the determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including NPS, NS, TS, NA, NW, and NPS/TS) from human patients with signs and symptoms of respiratory infection and/or from viral culture; For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors; To provide epidemiologic information for surveillance of the circulating influenza viruses. Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses. Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiological criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.	Influenza A Subtyping KitThe Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in Real-time RT-PCR assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument in conjunction with clinical and epidemiological information: For determination of the subtype of seasonal human influenza A virus as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs), and lower respiratory tract specimens (including bronchoalveolar lavages, bronchial washes, tracheal aspirates, sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture; To provide epidemiologic information for surveillance of the circulating influenza viruses. Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities. specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3+ facility is available to receive and culture specimens
	CDC Human Influenza Virus Real-time PCR Diagnostic Panel (K132508)	Influenza A Subtyping Kit
Intended Use (Cont'd)	Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3+ facility is available to receive and culture specimens.
Specimen Types	Nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs, bronchoalveolar lavages. bronchial aspirates, bronchial washes, tracheal aspirates, sputum, and lung tissue. Only upper respiratory specimens for influenza B genetic lineage determination	Nasopharyngeal swabs, nasal swabs, throat swabs, nasal aspirates, nasal washes and dual nasopharyngeal/throat swabs. bronchoalveolar lavages, bronchial aspirates, bronchial washes. tracheal aspirates, sputum, and lung tissue.
Technology	Real-time RT-PCR	Same
Required Instrumentation	Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4	Same
Organism Detected	Universal influenza A viruses (animal and human), Swine-origin influenza A viruses, Influenza B viruses, Influenza A subtypes: seasonal A/H1, A/H3, A/H1pdm09, and A/H5, Influenza B/Yamagata and B/Victoria lineages	Universal influenza A viruses (animal and human). Swine-origin influenza A viruses, Influenza A subtypes: seasonal A/H1. A/H3. A/H1pdm09
Nucleic Acid Extraction	Yes	Same

Table 1: Device Comparison

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New Special 510(K)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtybing Kiti
ng RT-PCR Diagnostic Partic

8-2

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New Special 510(k) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Risk Analysis

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel. A risk analysis of the labeling modification to create a separate package insert for the Influenza A Subtyping Kit was performed to verify that the change in the package insert did not present increased or new risks to the user. No new significant risks were identified as a result of the proposed modification.

Substantial Equivalence Conclusion

The changes proposed to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel do not alter the device's design or technological attributes. In addition, the indications for use and intended use of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel will remain the same. The modification to the package insert included with the Influenza A Subtyping Kit made available to users retains all required label information, and is determined to be substantially equivalent to the predicate.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contro] Center - WO66-G60 Silver Spring, MD 20993-0002

CENTERS FOR DISEASE CONTROL AND PREVENTION April 25, 2014 CDR YON YU, Pharm.D. ACTING ASSOCIATE DIRECTOR FOR REGULATORY AFFAIRS OFFICE OF THE DIRECTOR NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES 1600 CLIFTON ROAD, MS-C18 ATLANTA GA 30333

Re: K140851

Trade/Device Name: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OEP, OZE, NSU, OQW Dated: April 02, 2014 Received: April 03, 2014

Dear Dr. Yu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability. warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Dr. Yu

clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Uwe Scherf -S for

Sally Hoivat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known):

Device Name: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Indications For Use:

For determination of the subtype of seasonal human influenza A viruses as seasonal . A/H1, A/H3, and/or A/H1pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]), and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture:
To provide epidemiologic information for surveillance of circulating influenza ● viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H lpdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Page 1 of 2

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Li Li -S 2014.04.24 12:03:39 -04'00'

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.