The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3. respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.

Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.

Device Description

The ProParaflu+ Assay enables the detection and differentiation of Parainfluenza 1 Virus, Parainfluenza 2 Virus, Parainfluenza 3 Virus and an Internal Control (IC) nucleic acid. Nasopharyngeal swab specimens from symptomatic patients using a polyester, rayon or nylon tipped swab and place into viral transport medium. The IC is added to every sample prior to nucleic acid extraction to monitor for inhibitors present in the specimens.

Isolation and purification of nucleic acids is performed using the bioMérieux NucliSENS easyMAG automated extractor and the Automated Magnetic Extraction Reagents or the Roche MagNA Pure LC Instrument and the MagNA Pure Total Nucleic Acid Isolation Kit.

The purified nucleic acids are added to the ProParaflu+ Supermix along with enzymes included in the ProParaflu+ Detection Kit. The ProParaflu+ Supermix contains oligonucleotide primers that are complementary to highly conserved regions of hemagglutinin neuraminidase gene for each human Parainfluenza type (1, 2 and 3). The probes are dual-labeled with a reporter dye attached to the 5'-end and a quencher dye attached to the 3'-end.

RT-PCR amplification is performed in a Cepheid SmartCycler® II instrument. During this process, the primers and probes anneal specifically to the template (if present) followed by primer extension and amplification. The ProParaflu+ Assay is based on Taqman chemistry, which utilizes the 5' – 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing the fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification product present at that time. Fluorescent intensity is monitored during each PCR cycle by the real-time instrument. Results are analyzed and interpreted as presented by the software.

AI/ML Overview

Here's an analysis of the ProParaflu+ Assay's acceptance criteria and the studies performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. Instead, it presents the calculated sensitivity and specificity with 95% confidence intervals from the clinical studies. For the purpose of this summary, the reported performance metrics can be considered the demonstrated performance against which regulatory acceptance was evaluated.

Metric	Parainfluenza 1 (HPIV-1)	Parainfluenza 2 (HPIV-2)	Parainfluenza 3 (HPIV-3)
Prospective Study
Sensitivity	88.9% (67.2% - 96.9% CI)	96.3% (81.7% - 99.3% CI)	97.3% (86.2% - 99.5% CI)
Specificity	99.9% (99.3% - 100.0% CI)	99.8% (99.1% - 99.9% CI)	99.2% (98.1% - 99.5% CI)
Retrospective Study (HPIV-1 only)
Sensitivity	82.8% (65.4% - 92.4% CI)	N/A	N/A
Specificity	100% (94.2% - 100% CI)	N/A	N/A

Reproducibility:

Overall percent agreement with expected result: 97.8% for the initial reproducibility study.
Intermediate concentration study:
- HPIV-1: 56.7% agreement with positive result (expected due to concentration below LoD)
- HPIV-2: 86.7% agreement with positive result (expected due to concentration below LoD)
- HPIV-3: 30.0% agreement with positive result (expected due to concentration below LoD)

2. Sample Size and Data Provenance

Prospective Study:
- Sample Size (Test Set): 857 eligible nasopharyngeal (NP) swab samples.
- Data Provenance: United States (4 U.S. clinical laboratories), prospective collection from symptomatic individuals suspected of respiratory infection.
Retrospective Study (HPIV-1 only):
- Sample Size (Test Set): 91 frozen NP swab samples.
- Data Provenance: Not explicitly stated, but likely also US-based given the overall context. The data was retrospective, as samples were "previously tested by direct DFA."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number or qualifications of experts for establishing the ground truth.

4. Adjudication Method for the Test Set

Reference Method: Cell culture (rapid or traditional) followed by direct fluorescent antibody (DFA) screening and HPIV type identification was used as the primary reference method.
Discrepant Analysis: For samples where the ProParaflu+ Assay and the reference method disagreed, RT-PCR with virus-specific primers (different from those used in ProParaflu+) followed by bi-directional sequencing was performed. This served as an adjudication method to re-evaluate the true status of discrepant samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed. This device is a molecular diagnostic assay, not an imaging AI system designed to aid human interpretation.

6. Standalone Performance Study

Yes, the clinical performance studies (prospective and retrospective) represent a standalone performance evaluation of the ProParaflu+ Assay. The reported sensitivity and specificity figures reflect the algorithm's (assay's) performance without human intervention in the result determination beyond running the assay and interpreting its output according to established rules.

7. Type of Ground Truth Used

The ground truth was established through a combination of:

Reference Method: Cell culture (rapid or traditional) followed by direct fluorescent antibody (DFA) screening and HPIV type identification.
Confirmatory Method for Discrepancies: RT-PCR with virus-specific primers followed by bi-directional sequencing. This suggests a form of expert consensus or highly reliable confirmatory testing to resolve ambiguities.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For in vitro diagnostic assays like this, the development of the assay (primers, probes, conditions) inherently involves a form of "training" or optimization, but this is typically done using synthetic constructs, spiked samples, and smaller panels of clinical samples, not a formally defined "training set" in the machine learning sense. The clinical studies described (prospective and retrospective) are validation studies for the finalized device.

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

As no formal "training set" is described in the conventional sense for this type of device, the method for establishing ground truth for such a set is not detailed. The design of the assay (selection of conserved regions, primer/probe design) would have relied on existing genomic sequences and expert knowledge of the viruses.

Summary

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K09/053

Page 1 of 7 Date: November 5, 2009

Attachment D 510(k) SUMMARY

CONTACT

NOV 2 0 2009

Karen Harrington Gen-Probe Prodesse, Inc. W229 N1870 Westwood Dr. Waukesha, WI 53186

NAME OF DEVICE

Trade Name: Regulation Number: Classification Name:

ProParaflu+TM Assay 21 CFR 866.3980 Respiratory viral panel multiplex nucleic acid assay

PREDICATE DEVICE

K063765 - ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics

INTENDED USE

The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.

PRODUCT DESCRIPTION

Isolation and purification of nucleic acids is performed using the bioMérieux NucliSENS

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easyMAG automated extractor and the Automated Magnetic Extraction Reagents or the Roche MagNA Pure LC Instrument and the MagNA Pure Total Nucleic Acid Isolation Kit.

Analyte	Gene Targeted	ProbeFluorophore	AbsorbancePeak	EmissionPeak	InstrumentChannel
Parainfluenza 1Virus	Hemagglutininneuraminidase	FAM	495 nm	520 nm	FAM
Parainfluenza 3Virus	Hemagglutininneuraminidase	Cal Orange 560	540 nm	561 nm	TET
Parainfluenza 2Virus	Hemagglutininneuraminidase	Cal Red 610	595 nm	615 nm	Texas Red
Internal Control	NA	Quasar 670	647 nm	667 nm	Cy5

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SUBSTANTIAL EQUIVALENCE

Clinical Performance

The clinical performance of the ProParaflu+ Assay was established during a prospective study at 4 U.S. clinical laboratories during May 2008 - September 2009. Specimens used in the study represented excess nasopharyngeal (NP) swab specimens that were prospectively collected from symptomatic individuals suspected of respiratory infection, and were submitted for routine analysis. Demographic details for this patient population are summarized in the following table.

Sex	Number of Subjects
Female	407 (47.5%)
Male	450 (52.5%)
Age (yrs)
≤ 5 years	580 (67.7%)
6 - 21 years	168 (19.6%)
22 - 59 years	67 (7.8%)
≥ 60 years	42 (4.9%)

Gender and Age Demographic Detail for ProParaflu+ Prospective Study

Performance of the ProParaflu+ Assay was compared to the reference method of cell culture (rapid or traditional) followed by direct fluorescent antibody (DFA) screening and HPIV type identification.

A total of 857 eligible NP swab samples were tested with the ProParaflu+ Assay and by culture across four clinical sites. Of the ProParaflu+ Assay run on all eligible specimens, 99.2% (852/857) of these specimens were successful on the first attempt. The remaining 5 gave "Unresolved" results on the first attempt. Unresolved results occur when the sample is negative for all three HPIVs and the Internal Control, indicating potentially PCR-inhibiting samples. Of the 5 "Unresolved" specimens on the first attempt, 60.0% (3/5) gave a valid result on the second attempt. The remaining 2 were "Unresolved" on the second attempt and are not included in the analysis below. Both samples were culture negative.

Discrepant analysis for samples where ProParaflu+ Assay and culture results were in disagreement was performed using RT-PCR with virus specific primers obtained from literature® 9 (and different from those used in ProParaflu+) followed by bi-directional sequencing.

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Prospective Study

		Culture/DFA
		Positive	Negative	Total
ProParaflu+Assay	Positive	16	1a	17	Sensitivity 88.9% (67.2% - 96.9%) 95% CI
	Negative	2b	838	840	Specificity 99.9% (99.3% - 100.0%) 95% CI
	Total	18	839	857

Parainfluenza 1 Comparison Results

4One (1) sample positive for HPIV-1 by bi-directional sequence analysis.

bTwo (2) samples negative for HPIV-1 by bi-directional sequence analysis. One sample positive for HPIV-3 by ProParaflu+ and bi-directional sequence analysis.

Parainfluenza 2 Comparison Results

		Culture/DFA
		Positive	Negative	Total
ProParaflu+Assay	Positive	26	2a	28	Sensitivity 96.3% (81.7% - 99.3%)95% CI
	Negative	1b	828	829	Specificity 99.8% (99.1% - 99.9%)95% CI
	Total	27	830	857

4Two (2) samples positive for HPIV-2 by bi-directional sequence analysis.

bOne (1) sample negative for HPIV-2 by bi-directional sequence analysis.

Parainfluenza 3 Comparison Results

		Culture/DFA
		Positive	Negative	Total
ProParaflu+Assay	Positive	36	8a	44	Sensitivity 97.3% (86.2% - 99.5%)95% CI
	Negative	1b	812	813	Specificity 99.2% (98.1% - 99.5%)95% CI
	Total	37	820	857

4Seven (7) samples positive for HPIV-3 and one (1) sample negative for HPIV-3 by bidirectional sequence analysis.

bone (1) sample negative for HPIV-3 by bi-directional sequence analysis.

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Retrospective Study

Due to a minimal number of HPIV-1 positive samples, a retrospective study was also conducted using a total of 91 frozen NP swab samples that had been previously tested by direct DFA. Demographic details for this patient population are summarized in the following table.

Gender and Age Demographic Detail for ProParaflu+ Retrospective Study

Sex	Number of Subjects
Female	40 (44.4%)
Male	50 (55.6%)
Age (yrs)
≤ 5 years	81 (90.0%)
6 - 21 years	5 (5.6%)
22 – 59 years	2 (2.2%)
≥ 60 years	2 (2.2%)

Parainfluenza 1 Comparison Results

		DFA
		Positive	Negative	Total
ProParaflu+Assay	Positive	24	0	24	Sensitivity 82.8% (65.4% - 92.4%)95% CI
	Negative	5a	62	67	Specificity 100% (94.2% - 100%)95% CI
	Total	29	62	91

4Five (5) samples negative for HPIV-1 by bi-directional sequence analysis.

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ProParaflu Assay 510(k) Submission

Reproducibility

The reproducibility of the ProParaflu+ Assay was evaluated at 3 laboratory sites. Reproducibility was assessed using a panel of 12 simulated samples that included medium positive, low positive (near the assay limit of detection, ≥95% positive), intermediate (1 log below the assay limit of detection), and high negative (below the assay limit of detection, <5% positive) samples. Panels and controls were tested at each site by 2 operators for 5 days. The overall percent agreement with the expected result for the ProParaflu+ Assay was 97.8%.

Panel Member ID	HPIV-1 high negative"	HPIV-1 low positive	HPIV-1 medium positive	HPIV-2 high negative"	HPIV-2 low positive	HPIV-2 medium positive	HPIV-3 high negative"	HPIV-3 low positive	HPIV-3 medium positive	Para Extraction Control	Para RNA Control HPIV-1	HPIV-2	HPIV-3	Negative Control	Total % Agreement
Concentration	0.001 X LoD	2 X LoD	10X LoD	0.001 X LoD	2 X LoD	10X LoD	0.01 X LoD	2 X LoD	10X LoD	N/A	N/A	N/A	N/A	N/A
Site 1	Agreement with Expected Result	10/10100%	8/1080%	9/9100%	10/10100%	9/9100%	9/1090%	10/10100%	9/1090%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	114/11896.6%
	Mean Ct Value	27.73	28.31	26.33	27.90	28.62	26.27	27.76	31.21	29.47	27.33	27.37	29.37	28.61	27.69
	% CV	2.87	1.55	1.60	2.84	0.85	1.25	2.43	3.21	1.91	1.60	1.05	0.43	0.81	1.67
	Site 2	Agreement with Expected Result	8/1080%	8/1080%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%
Mean Ct Value		28.59	28.47	26.12	28.83	28.91	26.61	28.30	31.64	29.51	27.56	23.86	26.09	25.23	28.68
% CV		1.36	1.72	1.26	2.80	1.31	1.83	1.18	2.17	2.66	2.47	1.48	1.12	0.92	1.15
Site 3		Agreement with Expected Result	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%
	Mean Ct Value	26.35	29.91	27.67	26.28	29.51	27.44	26.67	33.13	30.43	28.61	28.73	30.98	29.84	26.46
	% CV	0.88	0.81	1.25	1.35	0.57	2.25	4.13	2.36	1.02	1.54	3.31	3.39	3.19	1.04
	Total Agreement with Expected Result	28/3093.3%	26/3086.7%	29/29100%	30/30100%	29/29100%	29/3096.7%	30/30100%	29/3096.7%	30/30100%	30/30100%	30/30100%			30/30100%	350/35897.8%
95% CI	78.7% -98.2%	70.3% -94.7%	88.3% -100%	88.6% -100%	88.3% -100%	83.3%-99.4%	88.6% -100%	83.3%-99.4%	88.6%-100%	88.6%-100%	88.6% - 100%			88.6%-100%	95.6% -98.9%
Overall Mean Ct Value	27.56	28.90	26.72	27.67	29.03	26.79	27.58	32.02	29.80	27.83	26.65	28.81	27.89	27.62
Overall % CV	3.88	2.87	2.95	4.55	1.57	2.54	3.68	3.61	2.42	2.75	8.13	7.49	7.39	3.54

*Average Ct value for the Internal Control (IC)

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An additional reproducibility study was performed to assess samples that were at an intermediate concentration, below the assay's LoD but above the "high negatives" tested during the original reproducibility study. The percent positive for the intermediate member across all sites was 56.7% for HPIV-1 (mean Ct = 35.1), 86.7% for HPIV-2 (mean Ct = 33.0), and 30.0% for HPIV-3 (mean Ct = 37.1). This result was expected as the intermediate concentration should be positive in the range of 5 - 95% as the samples were lower concentration than the LoD concentration (≥ 95% positive) and higher than the "high negative" concentration (< 5% positive).

	Panel Member ID	HPIV-1 intermediate	HPIV-2 intermediate	HPIV-3 intermediate	Para Extraction Control	Parainfluenza RNA Control			Negative Controla
	Concentration	0.1 X LoD	0.1 X LoD	0.1 X LoD	N/A	HPIV-1	HPIV-2	HPIV-3	N/A
Site 1	Agreement with Positive Result	4/1040%	8/1080%	1/1010%	10/10100%	10/10100%	10/10100%	10/10100%	10/10*100%
Site 1	Average Ct Value	35.5	33.3	36.9	27.9	28.8	30.4	29.5	28.4
Site 1	% CV	6.19	2.78	N/A	3.80	1.13	0.88	0.89	3.47
Site 2	Agreement with Positive Result	8/1080%	10/10100%	7/1070%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%
Site 2	Average Ct Value	34.4	32.2	37.3	27.5	29.0	30.6	29.9	27.7
Site 2	% CV	1.38	2.22	1.50	2.92	1.04	0.89	0.72	2.80
Site 3	Agreement with Positive Result	5/1050%	8/1080%	1/1010%	10/10100%	10/10100%	10/10100%	10/10100%	10/10100%
Site 3	Average Ct Value	35.9	33.7	35.8	28.6	29.7	31.5	30.3	27.9
Site 3	% CV	2.44	2.90	N/A	2.75	1.92	1.69	1.46	1.94
	Total Agreement with Positive Result	17/3056.7%	26/3086.7%	9/3030.0%	30/30100%	30/30100%	30/30100%	30/30100%	30/30100%
	95% CI	39.2% -72.6%	70.3% -94.7%	16.7% -47.9%	88.7 -100%	88.7 - 100%			88.7 - 100%
	Overall Average Ct Value	35.1	33.0	37.1	28.0	29.1	30.8	29.9	28.0
	Overall % CV	3.68	3.25	1.89	3.46	1.91	1.92	1.53	2.92

ª Average Ct value for the Internal Control (IC)

*Agreement with Negative result

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Image /page/7/Picture/0 description: The image contains a logo and some text. The logo is a circular emblem with a stylized image of an eagle or bird in the center. The text is partially visible and appears to be part of the circular emblem. The text is not fully legible, but it seems to be related to a government agency or organization.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Dr. Karen Harrington Manager, Clinical Affairs Prodesse Inc. W229 N1870 Westwood Drive Waukesha, WI 53186

NOV 2 0 2009

Re: K091053

Trade/Device Name: ProParaflu+ "M Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OQU Dated: October 14, 2009 Received: October 15, 2009

Dear Dr. Harrington:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

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limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Fally weArb

Sally A. Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K091053

Device Name: ProParaflu+TM Assay

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

the Schuf

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091053

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.