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

Intended 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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Date: March 3, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quidel Corporation Selena Liu Senior Regulatory Specialist 10165 McKellar Court San Diego, California 92121

Re: K230236

Trade/Device Name: Lyra Influenza A+B Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OZE, OOI Dated: January 27, 2023 Received: January 30, 2023

Dear Selena Liu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

# Himani Bisht -S

Himani Bisht. Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230236

Device Name Lyra Influenza A+B Assay

#### Indications for Use (Describe)

The Lyra Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of 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 endemiological 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 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.

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <table><tr><td><div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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### 510(K) SUMMARY

#### Submitter

Quidel Corporation 10165 McKellar Court San Diego, CA 92121 Telephone: [phone]

#### Submission Contact

Selena Liu Senior Regulatory Specialist [phone] [e-mail]

#### Date Prepared

Jan 27, 2023

#### Proprietary and Established Names

Lyra Influenza A+B Assay

#### Common Name

Lyra Influenza A+B Assay

#### Classification

| Product Code | Classification | Panel | Regulatory<br>Section | Description |
|--------------|----------------|-----------------------|-----------------------|-------------------------------------------------------------------|
| OZE | II | Microbiology | 21 CFR 866.3980 | Influenza A And<br>Influenza B<br>Multiplex Nucleic<br>Acid Assay |
| OOI | II | Clinical<br>Chemistry | 21 CFR 862.2570 | Real Time Nucleic<br>Acid Amplification<br>System |

#### Predicate Device

K131728

#### Device Description

The Lyra Influenza A+B Assay detects viral RNA that have been extracted from a patient sample using the NucliSENS easyMAG or EMAG automated extraction platform. A multiplex RT-PCR is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid® SmartCycler® II. Identification of influenza A occurs by the use of target specific primers and a fluorescent-labeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.

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#### Intended 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 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.

#### Comparison with Predicate

The Lyra Influenza A+B Assay was modified to include a validated nucleic acid extraction platform, BioMerieux NucliSENS EMAG. The predicate device was cleared under K131728 for use with the BioMerieux NucliSENS easyMAG extraction platform. The purpose of the change is to allow customers to continue to use Lyra Influenza A+B Assay after easyMAG is discontinued.

A comparison of the similarities and differences between the devices is provided in the following table.

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| Features | Predicate Device / Unmodified Device<br>Lyra Influenza A+B Assay (K131728) | Modified Device<br>Lyra Influenza<br>A+B Assay |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Intended Use | The Lyra Influenza A+B Assay is a multiplex Real<br>Time RT-PCR assay for the in vitro qualitative<br>detection and differentiation of influenza A and<br>influenza B viral RNA in nasal and nasopharyngeal<br>swabs from patients with signs and symptoms of<br>respiratory infection. This test is intended for use as<br>an aid in the differential diagnosis of influenza A<br>and influenza B viral infections in humans in<br>conjunction with clinical and epidemiological risk<br>factors. The assay does not detect the presence of<br>influenza C virus.<br><br>Negative results do not preclude influenza virus<br>infection and should not be used as the sole basis for<br>diagnosis, treatment or other patient management<br>decisions.<br><br>Performance characteristics for influenza A were<br>established during the 2011 and 2013 influenza<br>seasons when influenza A/H3 and 2009 H1N1<br>influenza were the predominant influenza A viruses<br>in circulation. When other influenza A viruses are<br>emerging, performance characteristics may vary.<br><br>If infection with a novel influenza A virus is<br>suspected based on current clinical and<br>epidemiological screening criteria recommended by<br>public health authorities, specimens should be<br>collected with appropriate infection control<br>precautions for novel virulent Influenza viruses and<br>sent to state or local health department for testing.<br>Viral culture should not be attempted in these cases<br>unless a BSL 3+ facility is available to receive and<br>culture specimens.<br><br>The assay can be performed using either the Life<br>Technologies QuantStudio™ Dx, the Applied<br>Biosystems® 7500 Fast Dx, or the Cepheid®<br>SmartCycler® II. | Same |
| Test Principle | Multiplex RT-PCR | Same |
| Detection Method | Multiplex assay using different reporter dyes for<br>each target | Same |
| Assay Result | Qualitative | Same |
| Analyte | Influenza A virus, influenza B virus | Same |
| Specimen Type | Nasal swab and nasopharyngeal swab | Same |
| Extraction Method | BioMerieux NucliSENS easyMAG | BioMerieux NucliSENS<br>easyMAG and EMAG |
| Quality Control | Process Control (PRC) | Same |

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#### Summary of Performance Data

Non-clinical and clinical verification activities conducted with the Lyra Influenza A+B Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness. Evidence is demonstrated through the following studies:

- Limit of Detection Equivalency Study ●
- Clinical Equivalency Study ●

#### Conclusion

These studies demonstrated equivalent performance of the Lyra Influenza A+B Assay to the predicate product K131728.