FilmArray Respiratory Panel EZ (RP EZ) is a multiplexed nucleic acid test intended for use with the FilmArray 2.0 EZ Configuration instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following organism types are identified using the FilmArray RP EZ: Adenovirus, Coronavirus, Human Metapneumovirus, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza Virus, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or, lower respiratory tract is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the FilmArray RP EZ may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Device Description

The FilmArray Respiratory Panel EZ (RP EZ) is a multiplex nucleic acid test designed to be used with the FilmArray 2.0 EZ Configuration instrument. The FilmArray RP pouch (a component of the FilmArray RP EZ test system) contains freeze-dried reagents to perform nucleic acid purification, reverse transcription, and nested, multiplex PCR with DNA melt analysis. FilmArray RP EZ simultaneously conducts 14 tests for the identification of respiratory pathogens from nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections (Table 1). Results from the FilmArray RP EZ test are available within about one hour.

A test is initiated by loading Hydration Solution and an unprocessed patient nasopharyngeal swab (NPS) specimen (i.e. specimen mixed with Sample Buffer) into the FilmArray RP pouch. The pouch contains all of the reagents required for specimen testing and analysis in a freezedried format; the addition of Hydration Solution and specimen/Sample Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray software guides the user though the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The FilmArray instrument contains a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel. In addition, electronically controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the FilmArray RPpouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the FilmArray performs a nested multiplex PCR that is executed in two stages. During the filmArray performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye (LCGreen® Plus, BioFire Defense, LLC). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 200 stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the array captures fluorescent images of the PCR reactions and software interprets the data.

The FilmArray software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

AI/ML Overview

Acceptance Criteria and Device Performance for FilmArray® Respiratory Panel EZ (RP EZ)

The provided document describes the FilmArray® Respiratory Panel EZ (RP EZ), a multiplexed nucleic acid test for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids. The information primarily focuses on establishing substantial equivalence to a predicate device and validating the device's performance in a CLIA-waived setting for external control testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for each pathogen) in the same way a direct clinical trial report might. Instead, the "acceptance criteria" presented are implied through validation studies demonstrating the device's intended use and substantial equivalence to a previously cleared device.

However, the document does report on a study for external control testing, for which we can infer an acceptance criterion.

Aspect of Performance	Acceptance Criteria (Implied)	Reported Device Performance
External Control Testing Accuracy	Intended users should accurately acquire and interpret results for positive and negative external controls.	98.9% (178/180) overall correct control test results
Positive Control Recognition	100% of positive controls should be correctly identified.	100% (90/90) of positive controls correctly identified
Negative Control Recognition	High percentage of negative controls should be correctly identified.	97.8% (88/90) of negative controls correctly identified
Functional Equivalence to Predicate Device	Device should operate with similar technological principles and provide comparable results to the predicate.	Demonstrated through comparison table and V&V of software.

Study Proving Device Meets Acceptance Criteria (External Control Testing)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded due to invalid results, resulting in 180 control tests for analysis.
Data Provenance: The study was conducted at "three locations" (sites) by "multiple operators" with "training and educational backgrounds consistent with those in the CLIA-waived testing environment." The document does not specify the country of origin, but given the FDA submission, it is likely the USA. The study design appears to be prospective, specifically designed for this validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This study focused on validating the ability of intended users to perform external control testing. The "ground truth" for the external controls (i.e., whether they were positive or negative for all analytes) was established by the manufacturer (Maine Molecular Quality Controls, Inc., and BioFire Diagnostics) during their manufacturing and quality control processes. No independent experts were used to establish the ground truth for these pre-defined control materials in this particular user study.

4. Adjudication Method for the Test Set:

Not applicable. The study evaluated the direct interpretation of the device results by the users against the known composition of the external controls. There was no need for expert adjudication over user interpretations as the controls have a fixed "ground truth."

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This study solely assessed the ability of individual users (readers) to correctly operate the device and interpret the results of pre-defined external controls in a CLIA-waived setting. It did not compare the effectiveness of human readers with or without AI assistance, as the device itself is a diagnostic test, not an AI interpretative tool for human readers.

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

Yes, in a sense. The FilmArray RP EZ is a fully automated, standalone diagnostic system. The "algorithm only" performance is inherent in the device's ability to process the sample, perform PCR, and interpret the melt curve analysis to generate a result. The external control study demonstrated that the device itself (operated by an intended user) accurately produced results for known control materials. The results reported (e.g., 98.9% overall correct) represent the standalone performance of the device when operated by its intended user, as the interpretation of the results is automated by the device's software.

7. The Type of Ground Truth Used:

For the external control testing, the ground truth was known composition of control materials. The external controls (M265, M266, M267) were manufactured with a defined positive (containing all FilmArray RP EZ analytes) or negative (containing no analytes) composition.

8. The Sample Size for the Training Set:

The document explicitly states that "User training on use of the FilmArray RP EZ was limited to the training video and quick guide provided with the EZ system." There isn't a formally described "training set" in the context of machine learning model development. The users in this study received standard instructional materials provided with the device.

9. How the Ground Truth for the Training Set Was Established:

As there was no formal "training set" in the machine learning sense, this question is not directly applicable. The "training" for the human users was provided through the manufacturer's training video and quick guide, which would convey the correct operational procedures and interpretation guidelines for the device. The ground truth for the device's internal algorithm (which is the "AI" component here, though not explicitly termed AI) was established through extensive analytical and clinical studies described in previous 510(k) submissions (K103175, K110764, K120267, K123620, K143080), as referenced in the document. These foundational studies would have leveraged expert consensus, comparator methods (like PCR, culture, and sequencing), and clinical outcomes data to establish the ground truth for pathogen detection.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

October 3, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BioFire Diagnostics, LLC Kristen J. Kanack, Ph.D. Vice President of Regulated Products and Clinical Affairs 390 Wakara Way Salt Lake City, UT 84108

Re: K152579

Trade/Device Name: FilmArray® Respiratory Panel EZ (RP EZ) Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: II Product Code: OCC. OEM. OOU. OEP. OTG. OOW. OOI. OZZ. OZY, OZX Dated: June 2, 2016 Received: June 3, 2016

Dear Dr. Kanack:

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

{1}------------------------------------------------

electronic 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Uwe Scherf -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152579

Device Name FilmArray® Respiratory Panel EZ (RP EZ)

Indications for Use (Describe)

Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus, Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B. Mycoplasma pneumoniae, and Parainfluenza Virus were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens.

Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray RP EZ cannot reliably differentiate them. A positive FilmArray RP EZ Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required.

Performance characteristics for Influenza A were established when Influenza A H1-2009, A H1, and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary BioFire Diagnostics, LLC

FilmArrav Respiratory Panel EZ (RP EZ)

Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitted by:

BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108

Telephone: 801-736-6354 Facsimile: 801-588-0507

Contact: Kristen Kanack, ext. 330

Date Submitted: September 04, 2015

Device Name and Classification:

Trade Name: FilmArray Respiratory Panel EZ (RP EZ)

Regulation Number: 21 CFR 866.3980

Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay

Product Codes: OCC, OEM, OOU, OEP, OTG, OOI, OZX, OZY, OOW and OZZ

Predicate Device:

K143080 - FilmArray Respiratory Panel for use with FilmArray 2.0 System and FilmArray Injection Vials

Intended Use:

{5}------------------------------------------------

aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or, lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the FilmArray RP EZ may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus, Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, and Parainfluenza Virus were established primarily with retrospective clinical specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using contrived clinical specimens.

Performance characteristics for Influenza A were established when Influenza A H1-2009, A H1, and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Description:

Viral Targets Detected	Bacterial Targets Detected
Adenovirus	Bordetella pertussis
Coronavirus	Chlamydophila pneumoniae

Table 1. Pathogens Detected by the FilmArray RP EZ

{6}------------------------------------------------

Human Metapneumovirus	Mycoplasma pneumoniae
Human Rhinovirus/EnterovirusInfluenza A, including subtypesH1, H3 and H1-2009Influenza BParainfluenza VirusRespiratory Syncytial Virus

Substantial Equivalence:

{7}------------------------------------------------

The FilmArray Respiratory Panel EZ is substantially equivalent to the FilmArray Respiratory Panel for use with FilmArray 2.0 and FilmArray Injection Vials (K143080), which was cleared on February 17, 2015 and determined to be a Class II device.

The following table compares the FilmArray Respiratory Panel EZ to the previously cleared FilmArray Respiratory Panel for use with FilmArray System 2.0 and FilmArray Injection Vials (K143080). The table outlines the similarities and differences between the two systems.

Element	New Device:FilmArray Respiratory Panel EZ (for usewith FilmArray 2.0 EZ Configuration)	Predicate:FilmArray Respiratory Panel for usewith FilmArray System 2.0 andFilmArray Injection Vials(K143080)
OrganismsDetected	Influenza A, Influenza A subtype H1,Influenza A subtype H3, Influenza Asubtype 2009 H1, Influenza B, RespiratorySyncytial Virus, Human Metapneumovirus,Adenovirus, Parainfluenza, HumanRhinovirus/Enterovirus, Coronavirus,Mycoplasma pneumoniae, Chlamydophilapneumoniae, and Bordetella pertussis.	Influenza A, Influenza A subtype H1,Influenza A subtype H3, Influenza Asubtype 2009 H1, Influenza B, RespiratorySyncytial Virus, Human Metapneumovirus,Adenovirus, Parainfluenza 1, Parainfluenza2, Parainfluenza virus 3, Parainfluenza 4,Human Rhinovirus/Enterovirus,Coronavirus HKU1, Coronavirus NL63,Coronavirus 229E, Coronavirus OC43,Mycoplasma pneumoniae, Chlamydophilapneumoniae, and Bordetella pertussis.
Analyte	RNA/DNA	Same
Specimen Types	Nasopharyngeal swabs	Same
TechnologicalPrinciples	Nested multiplex RT-PCR followed by highresolution melting analysis to confirmidentity of amplified product.	Same
Instrumentation	FilmArray 2.0 EZ Configuration	FilmArray or FilmArray 2.0
Time to result	About 1 hour	Same
TestInterpretation	Automated test interpretation and reportgeneration.	Same
ReagentHydration andSample Loading	FilmArray Injection Vial-based loadingprocedure.	Same
SamplePreparationMethod	Sample Processing is automated in theFilmArray RP pouch.	Same
Reagent Storage	Reagents are stored at room temperature.	Same
Controls	Two controls are included in each reagentpouch to control for sample processing andboth stages of PCR and melt analysis.	Same
Element	New Device:FilmArray Respiratory Panel EZ (for usewith FilmArray 2.0 EZ Configuration)	Predicate:FilmArray Respiratory Panel for usewith FilmArray System 2.0 andFilmArray Injection Vials(K143080)
UserComplexity	Low	Moderate

Table 2. Comparison of the FilmArray Respiratory Panel EZ to the FilmArray Respiratory Panel for use with FilmArray System 2.0 and FilmArray Injection Vials.

{8}------------------------------------------------

Summary of Supporting Data:

Previous Clinical and Analytical Studies

The FilmArray RP reagent pouch and the FilmArray 2.0 instrument (both of which are components of the FilmArray RP EZ system) remain unchanged. Clinical and Analytical performance data have been provided in previous 510(k) submissions (K103175, K110764, K120267, K123620, K143080).

Verification and Validation (V&V) of Software Modifications:

The FilmArray EZ software was modified from the FilmArray 2.0 software by removing the multi-instrument dashboard and ability to run multiple instruments, removing PCR evaluator, and simplifying the user interface. In addition, the FilmArray RP EZ pouch module was modified from the FilmArray RP pouch module in order to simplify the results report format and also to combine all four Parainfluenza Virus subtypes into a single Parainfluenza Virus result and all four Coronavirus subtypes into a single Coronavirus result. Verification and Validation activities comprising automated and manual test cases confirmed that the FilmArray EZ software and the FilmArray RP EZ pouch module function as intended when used together in the FilmArray RP EZ test system.

External Control Material:

BioFire recommends the use of an external control panel manufactured by Maine Molecular Quality Controls, Inc., Scarborough, ME (online at www.mmqci.com) to be used with the FilmArray RP EZ:

FilmArray RP EZ Control Panel M265, Part number M265 (Also available as BioFire Diagnostics Part Number CHEM-CTL-0001)

6 vials of RP EZ Positive M266, Part number M266 .
6 vials of RP EZ Negative M267, Part number M267 .

The panel is comprised of six individual ready-to-use vials of a positive control material (containing all FilmArray RP EZ analytes) and six individual ready-to-use vials of a negative control material (containing no analytes). This external control panel should be tested when receiving a new shipment of test pouches and when training a new user.

{9}------------------------------------------------

A study was performed to assess the ability of the intended user to perform external control testing using the recommended control material and testing procedure for the FilmArray Respiratory Panel (RP) EZ in a CLIA-waived setting. The primary metric evaluated by this study was the ability of these users to acquire and accurately interpret FilmArray RP EZ results when testing the provided external control material. The RP EZ test was performed according to the manufacturer's instructions by users with training and educational backgrounds consistent with those in the CLIA-waived testing environment (i.e. the intended users). User training on use of the FilmArray RP EZ was limited to the training video and quick guide provided with the EZ system.

Testing consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of RP EZ pouches were tested across all sites.

A total of 182 external controls were tested (91 positive and 91 negative) by RP EZ users. Two tests were excluded from final data analysis due to invalid results caused by internal pouch control failures. Data for the remaining 180 control tests are shown below in Table 1.

Site	Positive	Negative	Total
Site 1	30/30(100%)	28/30(93.3%)	58/60(96.7%)
Site 2	30/30(100%)	30/30(100%)	60/60(100%)
Site 3	30/30(100%)	30/30(100%)	60/60(100%)
Total	90/90(100%)	88/90(97.8%)	178/180(98.9%)

Table 1. Summary of RP EZ external control test results

Overall, the users acquired correct control test results in 98.9% of the controls tested, indicating that intended users can accurately perform external control testing in the intended use setting.

Conclusion:

The fundamental scientific technology of the FilmArray RP reagent pouch and FilmArray 2.0 instrument remain unchanged components of the new FilmArray RP EZ system. Data presented demonstrate that the FilmArray RP EZ for use with the FilmArray 2.0 EZ Configuration, which contain modifications to increase simplicity of test use, is substantially equivalent to the FilmArray RP for use with the FilmArray 2.0 system.

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.