Lyra Influenza A+B Assay

K230236 · Quidel Corporation · OZE · Mar 3, 2023 · Microbiology

Device Facts

• Record ID: K230236
• Device Name: Lyra Influenza A+B Assay
• Applicant: Quidel Corporation
• Product Code: OZE · Microbiology
• Decision Date: Mar 3, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The Lyra Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2011 and 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. 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 in these cases unless a BSL 3+ facility is available to receive and culture specimens. The assay can be performed using either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid® SmartCycler® II.

Device Story

Multiplex Real Time RT-PCR assay; detects influenza A and B viral RNA. Input: nasal/nasopharyngeal swabs; RNA extracted via BioMerieux NucliSENS easyMAG or EMAG platforms. Process: single-tube RT-PCR; target-specific primers and fluorescent-labeled probes hybridize to conserved influenza A matrix protein gene and influenza B neuraminidase gene. Output: qualitative detection of influenza A and B. Used in clinical laboratories; operated by trained personnel. Results interpreted by healthcare providers to aid in differential diagnosis of respiratory infections; negative results do not rule out infection. Benefits: rapid, specific identification of influenza A/B to guide patient management.

Clinical Evidence

Clinical equivalency study and Limit of Detection (LOD) equivalency study conducted. Verification activities confirmed the modified device met all predetermined acceptance criteria, demonstrating performance equivalent to the predicate device (K131728).

Technological Characteristics

Multiplex nucleic acid assay; utilizes nucleic acid extraction and amplification. Modification integrates bioMerieux EMAG system for extraction. Fundamental scientific technology remains consistent with previously cleared device.

Indications for Use

Indicated for the qualitative detection of Influenza A and Influenza B viral RNA in respiratory specimens.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Lyra Influenza A+B Assay (K230236)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K230236

B Applicant

Quidel Corporation

C Proprietary and Established Names

Lyra Influenza A+B Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OZE | Class II | 21 CFR 866.3980 - Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI - Microbiology |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for the addition of bioMerieux EMAG nucleic acid extraction system for use with the Lyra Influenza A+B assay.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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