Lyra RSV+hMPV Assay

K230349 · Quidel Corporation · OEM · Mar 10, 2023 · Microbiology

Device Facts

• Record ID: K230349
• Device Name: Lyra RSV+hMPV Assay
• Applicant: Quidel Corporation
• Product Code: OEM · Microbiology
• Decision Date: Mar 10, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The Lyra RSV + hMPV Assay is a multiplexed real-time RT-PCR assay for the qualitative detection and differentiation of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) viral RNA in nasal and nasopharyngeal swab specimens from individuals suspected of respiratory tract infections by their healthcare provider. The assay is intended to aid in the differential diagnosis of RSV and hMPV infections in humans. Negative results do not preclude RSV and hMPV infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is intended for use by professional laboratory personnel.

Device Story

Multiplex RT-PCR assay; detects RSV and hMPV RNA from nasal/nasopharyngeal swabs; utilizes automated nucleic acid extraction (NucliSENS easyMAG or EMAG); performs amplification in single tube; uses target-specific primers and fluorescent-labeled probes; requires external RT-PCR instrumentation (QuantStudio Dx, 7500 Fast Dx, or SmartCycler II). Used in clinical laboratory settings; results interpreted by healthcare providers to aid differential diagnosis of respiratory infections; does not differentiate RSV subtypes or hMPV sub-lineages; negative results do not rule out infection; positive results do not rule out co-infection or bacterial etiology.

Clinical Evidence

Verification and validation activities included a Limit of Detection (LoD) equivalency study and a clinical equivalence study. Testing demonstrated that the modified device met all predetermined acceptance criteria and performed equivalently to the predicate device (K131813). No new safety or effectiveness issues were raised.

Technological Characteristics

Multiplex real-time RT-PCR assay. Nucleic acid extraction performed via bioMérieux NucliSENS EMAG system. Analyzes nasal and nasopharyngeal swab specimens. Fundamental technology is nucleic acid amplification; no changes to core assay chemistry or detection principle.

Indications for Use

Indicated for qualitative detection and identification of RSV and hMPV RNA in nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection; intended to aid in differential diagnosis in conjunction with clinical and epidemiological risk factors.

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

• Quidel Molecular RSV + hMPV Assay (K131813)

Submission Summary (Full Text)

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SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

I Background Information:

A 510(k) Number
K230349

B Applicant
Quidel Corporation

C Proprietary and Established Names
Lyra RSV + hMPV Assay

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OEM, OCC | Class II | 21 CFR 21 CFR 866.3980
- Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI-Microbiology |

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.
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 the bioMérieux NucliSENS EMAG nucleic acid extraction system for use with the Lyra RSV+hMPV Assay. The predicate device was cleared for use with the bioMérieux NucliSENS easyMAG

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extraction platform. The purpose of the change is to allow customers to continue to use Lyra RSV + hMPV Assay after the NucliSENS easyMAG is discontinued.

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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