The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified nasopharygeal swab (NPS) and nasopharygeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection.

The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.

Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 biosafety (BSL) 3+ facility is available to receive and culture specimens.

Device Description

The JBAIDS Influenza A & B Detection Kit is a rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA. These two assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A and B viral RNA. In particular, the influenza A assay targets a region of the matrix gene specific to the influenza A virus genera, and the influenza B assay targets a region of the nonstructural gene specific to the influenza B virus genera. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay (RNAse P target) will be used as an inhibition and extraction control.

AI/ML Overview

The provided text describes the JBAIDS Influenza A & B Detection Kit, a real-time PCR assay for the qualitative in vitro detection of influenza A and B viral nucleic acids. The information primarily focuses on the technical aspects of the device and its substantial equivalence to a previously cleared predicate device, especially regarding the detection of specific influenza strains.

However, the document does not contain the kind of information typically found in a study proving a new device meets acceptance criteria, specifically not for an AI/ML-based diagnostic or imaging device. The document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against acceptance criteria in the way one would for a novel device, especially one involving AI.

Therefore, many of the requested items (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable or cannot be extracted from this document, as it describes a PCR-based diagnostic kit, not an AI/ML device.

Given the constraints of the provided document, I will extract the available relevant information and note where information is not present or non-applicable given the nature of the device described.

Acceptance Criteria and Device Performance (Limited to Analytical Sensitivity/LoD)

The document describes selected analytical studies to determine the Limit of Detection (LoD) for certain influenza A strains, specifically H3N2 and H7N9, which were additions to the device's labeling. This can be interpreted as demonstrating the device's performance against an implicit analytical sensitivity acceptance criterion.

Table 1: Acceptance Criteria (Implied Analytical Sensitivity) and Reported Device Performance

Criterion/Performance Metric	Acceptance Criterion (Implicit)	Reported Device Performance
Analytical Sensitivity (LoD)	Detection of target influenza strains at low concentrations (standard method for establishing LoD, typically requiring ≥95% positivity at LoD).	H7N9 (A/Anhui/1/2013):- Estimated LoD: 4 x 10^4^ EID50/mL (confirmed)- 3/3 replicates positive at 4 x 10^4^ EID50/mL- 2/3 replicates positive at 8.0 x 10^3^ EID50/mLInfluenza A H3N2 (seasonal):- A/Victoria/361/2011: LoD = 63.0 TCID50/mL- A/Perth/16/2009: LoD = 6.3 TCID50/mLInfluenza A swine variant H3N2v:- A/West/Virginia/06/2011: LoD = 31.6 TCID50/mL- A/Minnesota/11/2010: LoD = 2.0 TCID50/mL

Note: The document explicitly states: "Serial dilutions were run in triplicate, with all three replicates required to read positive in order for that dilution to be called positive." This stringent requirement for calling a dilution positive influences the reported LoD values.

Study Details:

Sample sizes used for the test set and the data provenance:
- Test set sample size: Not specified as a distinct "test set" in the context of clinical validation data for a new device. The data presented is for analytical sensitivity (LoD) testing.
  - For LoD, serial dilutions of viral strains were tested. The number of replicates per dilution is specified: "Serial dilutions were run in triplicate." It is implied that multiple concentrations were tested for each strain.
- Data provenance: Not explicitly stated for all strains, but the H3N2v and H7N9 strains suggest a focus on variant strains that would have emerged more recently (e.g., A/Anhui/1/2013 for H7N9). The samples were "simulated nasopharyngeal swab samples" meaning they were laboratory-prepared samples rather than clinical patient specimens. The study is described as "Selected Analytical Studies", indicating a laboratory-based evaluation of the assay itself. This falls under retrospective data generated in a controlled lab setting, not real-world clinical samples. No country of origin for test data is specified beyond the DoD context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For an analytical sensitivity study of a PCR-based diagnostic kit, the "ground truth" is typically defined by the known concentration of the purified viral standard used to prepare the simulated samples. This does not involve human expert interpretation of results, as the device provides a qualitative "positive, negative, or uncertain" result based on fluorescence thresholds.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As the "ground truth" is based on known viral concentrations in simulated samples and the device provides an automated qualitative result, there is no human adjudication process involved in interpreting the device's output or establishing the true state of the samples. The requirement for positivity was "all three replicates required to read positive".
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 device is a molecular diagnostic (PCR-based) kit, not an AI-assisted imaging device or a diagnostic requiring human reader interpretation in the context of an MRMC study design. It delivers an objective "positive/negative" result based on molecular detection.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The JBAIDS kit itself, when used with the JBAIDS instrument and software, performs the detection and provides a result (positive, negative, or uncertain) without requiring human diagnostic interpretation of complex outputs like images. The document states: "JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the analytical studies described, the ground truth was based on known concentrations of purified viral strains (e.g., EID50/mL or TCID50/mL) in simulated samples. This is a highly controlled laboratory ground truth, not clinical ground truth from patients (like pathology or outcomes data).
The sample size for the training set:
- Not applicable/Not specified. This document describes a traditional real-time PCR diagnostic kit, not an AI/ML device that requires a training set in the machine learning sense. The "training" of such a device involves optimizing primer/probe sets and reaction conditions during its development, not training on a large dataset like an AI model.
How the ground truth for the training set was established:
- Not applicable. (See point 7). The "ground truth" during the development of such a PCR kit would involve characterizing the specificity and sensitivity of the molecular components against known viral targets and non-targets, rather than establishing ground truth for a training set in an AI/ML context.

Summary

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

October 1, 2015

U.S. Army Medical Materiel Development Activity Robert Miller, PhD, RAC Director, Division of Regulated Activities and Compliance 1430 Veterans Drive Fort Detrick, MD 21702-9232

Re: K152523

Trade/Device Name: JBAIDS Influenza A & B Detection Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC Dated: September 2, 2015 Received: September 3, 2015

Dear Dr. Miller:

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

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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,

Tamara V. Feldblyum -S for

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

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Indications for Use

510(k) Number (if known) K152523

Device Name JBAIDS Influenza A & B Detection Kit

Indications for Use (Describe)

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza B viral nucleic acids isolated and purified NPS and NPW specimens from human patients with signs and symptoms of respiratory infection.

Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary. All users, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 biosatory (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)

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle in the center with its wings spread. The eagle is holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and the words "UNITED STATES OF AMERICA" are written around the bottom of the circle.

DEPARTMENT OF THE A U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009

510(k) Summary

1. 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.

2.Administrative Information
Submitted by:	The Surgeon General, Department of the Army
Primary Contact:	Robert Miller, PhD, RACDirector, Division of Regulated Activities and ComplianceTelephone: 301-619-0317Fax: 301-619-0197Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil
Secondary Contact:	Chandar Thakur, PhD, RACRegulatory Affairs Scientist, Division of Regulated Activities andComplianceTelephone: 301-619-2979Fax: 301-619-0197Email: chandar.s.thakur.ctr@mail.mil or usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil
Technical Contact:	Cynthia Phillips, PhDDirector, Regulated Products, BioFire Defense, LLCTelephone:801-262-3592, ext 1370Fax: 801-447-6907Email: cynthia.phillips@biofiredefense.com
3.Device
Device Name/ Trade Name:	JBAIDS Influenza A & B Detection Kit
Common Name:	Real-time PCR assay for detection of Influenza A and Influenza B
Classification Name:	Respiratory viral panel multiplex nucleic acid assay (21 CFR866.3980)

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Image /page/4/Picture/0 description: The image is the seal of the Department of Defense. The seal is circular and contains an eagle with its wings spread, holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the seal, and "UNITED STATES OF AMERICA" are written around the bottom.

DEPARTMENT OF THE AR U.S. ARMY MEDICAL MATERIEL DEVELOPMENT 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-500

4. Intended Use

5. Device Description

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Image /page/5/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with its wings spread, clutching arrows and an olive branch. Above the eagle are 13 stars arranged in an arc. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" is written around the bottom.

DEPARTMENT OF THE AR U.S. ARMY MEDICAL MATERIEL DEVELOPMENT 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009

6. Assay Principle

Before testing, NPS or NPW specimens are purified using Idaho Technology's 1-2-3TM Platinum Path Sample Purification Kit or the Roche MagNA Pure Compact Nucleic Acid Isolation Kit I. The resulting purified sample is added to unknown reagent vials and a sample control reagent vial, along with reconstitution buffer. When viral RNA is present, a fragment of influenza A or B viral RNA is transcribed and amplified. The amplicon is detected by fluorescence using a specific hydrolysis probe. Each probe is labeled on one end with a fluorescent reporter moiety (6-carboxyfluorescein (6-FAM)) and elsewhere with a quencher moiety (carboxy tetramethylrhodamine (TAMRA)). When the probe is intact, the quencher absorbs the light emitted by the reporter moiety. During PCR, the probe hybridizes to the target sequence before the exonuclease activity of Taq polymerase hydrolyzes the probe, separating the fluorophore from the quencher and permitting detection of the fluorescent signal generated by the reporter. The fluorescent signal increases as additional templates are amplified and more probes are hydrolyzed. JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain. A failure of the positive control will result in the entire run being called invalid. Failure of the sample control vields a result of "sample control failure" when the associated sample has a negative result for the target assay. Retesting is required to resolve uncertain, invalid, or sample control failure results.

7. Substantial Equivalence

The modified JBAIDS Influenza A & B Detection System is substantially equivalent to the current legally marketed device. JBAIDS Influenza A & B Detection Kit. Additions made to the labeling to add additional strain testing did not change the intended use of the device or the fundamental scientific technology.

The JBAIDS Influenza A & B Detection Kit with additional labeling for detection of Influenza A H3N2v and H7N9 strains described is substantially equivalent to the JBAIDS Influenza A & B Detection Kit, which was cleared on September 13, 2011 under 510(k) K111775.

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Image /page/6/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with its wings spread, holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" are written around the bottom.

DEPARTMENT OF THE ARN U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009

Table 1: Similarities Between the JBAIDS Influenza A & B Detection Kit (this submission) and the JBAIDS Influenza A & B Detection Kit (K111775)

Element	JBAIDS Influenza A and B Detection kit(this submission)	JBAIDS Influenza A and BDetection kit (K111775)
Technology	Real time PCR using hydrolysis probes	Same
Viruses Detected	Qualitative in vitro detection of InfluenzaA and Influenza B virus nucleic acids	Same (see Table 2)
Specimen Types	Nasopharyngeal swabs andNasopharyngeal washes	Same (see Table 2)
Extraction Methods	IT 1-2-3TM Platinum Path SamplePurification Kit and Roche MagNA PureCompact Nucleic Acid IsolationKit I	Same (see Table 2)
Required Instrumentation	JBAIDS Instrument	Same
Interpretation of TestResults	Automated analysis of test results andcontrols	Same
Reagent Storage	Reagents are stored at room temperature	Same

Table 2: Differences Between the JBAIDS Influenza A & B Detection Kit (this submission) and the JBAIDS Influenza A & B Detection Kit (K111775)

Element	JBAIDS Influenza A and B Detection kit(this submission)	JBAIDS Influenza A and BDetection kit (K111775)
Organisms Detected	Demonstrated inclusive detection ofInfluenza A H3N2v and A H7N9 aspositive for Influenza A	Not labeled for detection ofInfluenza A H3N2v and H7N9.
Specimen Types	Demonstrated detection of A H3N2v and AH7N9 from simulated nasopharyngealswabs. No testing of these strains has beenperformed on nasopharyngeal washes.	Nasopharyngeal swabs andwashes
Extraction methods	Demonstrated detection of Influenza AH3N2v and A H7N9 from simulatednasopharyngeal swab samples extractedusing the IT 1-2-3TM Platinum Path SamplePurification Kit. No testing of these strainswas performed on samples extracted usingthe Roche MagNA Pure Compact NucleicAcid Isolation Kit.	IT 1-2-3TM Platinum Path SamplePurification Kit and Roche MagNAPure Compact Nucleic AcidIsolation Kit

8. Selected Analytical Studies

The estimated analytical sensitivity or Limit of Detection (LoD) was determined for four strains of A H3N2 (two seasonal A H3N2 strains, and two swine variant, or A H3N2v, strains) and one strain of H7N9 using the Flu A assay. Simulated nasopharyngeal swab samples were extracted using the IT 1-2-3™ Platinum Path Sample Purification Kit prior to testing with the JBAIDS

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Image /page/7/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle with outstretched wings in the center. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written around the top of the circle, and "UNITED STATES OF AMERICA" are written around the bottom.

DEPARTMENT OF THE A U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MARYLAND 21702-5009

Influenza A & B Detection kit. Serial dilutions were run in triplicate, with all three replicates required to read positive in order for that dilution to be called positive. Results are shown in Table 3 and Table 4. This data was added to the analytical inclusivity section of the package insert.

Estimation studies suggested that the LOD for H7N9 was 4 x 104 EID50 /mL. Upon refinement and running further replicates, the confirmed LOD for H7N9 was determined to be 4 x 10 EIDs0 /mL. LOD estimation studies suggested that the LOD for H3N2v was between 2 and 32 TCID-0 /mL.

Strain	Concentration	No. PositiveReplicates
A/Anhui/1/2013	8.0 x 105 EID50/ml	3/3
A/Anhui/1/2013	4.0 x 105 EID50/ml	3/3
A/Anhui/1/2013	8.0 x 104 EID50/ml	3/3
A/Anhui/1/2013	4.0 x 104 EID50/ml	3/3
A/Anhui/1/2013	8.0 x 103 EID50/ml	2/3
A/Anhui/1/2013	4.0 x 103 EID50/ml	2/3
A/Anhui/1/2013	8.0 x 102 EID50/ml	1/3
A/Anhui/1/2013	4.0 x 102 EID50/ml	0/3
A/Anhui/1/2013	8.0 x 101 EID50/ml	2/3
A/Anhui/1/2013	4.0 x 101 EID50/ml	0/3

Table 3: Estimated LoD of H7N9 (A/Anhui/1/2013)

Estimated LoD of H3N2 and H3N2v Strains Table 4:

Strain	Isolate	LoD (TCID50/mL)
Influenza A H3N2 (seasonal)	A/Victoria/361/2011	63.0
Influenza A H3N2 (seasonal)	A/Perth/16/2009	6.3
Influenza A swine variant H3N2v	A/West/Virginia/06/2011	31.6
Influenza A swine variant H3N2v	A/Minnesota/11/2010	2.0

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Image /page/8/Picture/0 description: The image is a black and white seal for the Department of Defense. The seal is circular and contains an eagle holding arrows and an olive branch. Above the eagle are 13 stars arranged in a semi-circle. The words "DEPARTMENT OF DEFENSE" are written along the top of the circle, and "UNITED STATES OF AMERICA" are written along the bottom.

9. References

Centers for Disease Control and Prevention. Influenza A (H3N2) Variant Virus. Accessed: 26 Aug 2015: Available from: http://www.cdc.gov/flu/swineflu/h3n2v-cases.htm.

Clinical and Laboratory Standards Institute. Protocols for Determination of Limits of Detection and Limits of Quantitation. CLSI Approved Guidance EP17-A (2004).

Clinical and Laboratory Standards Institute. Evaluation of Precision Performance of Quantitative Measurements Methods; Approved Guidance-Second Edition, CLSI Approved Guidance EP5-A2 (August 2004).

United States Food and Drug Administration. In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path, Guidance for Industry and FDA Staff (May 1, 2007).

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.