Lyra Influenza A+B Assay
FDA 510(k) K230236 · Quidel Corporation
510(k) numberK230236
Submission
- Device name
- Lyra Influenza A+B Assay
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- January 30, 2023
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and…
Other 510(k)s with product code OZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 03/14/2025SE |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special | Centers for Disease Control and Prevention | 05/21/2024SE |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE · Special | Abbott Diagnostics Scarborough, Inc. | 06/24/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | Centers for Disease Control and Prevention | 03/10/2020SE |
| K182513 | FluChip-8G Influenza A+B AssayOZE · Traditional | Indevr, Inc. | 04/22/2019SE |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 03/27/2019SE |
| K190204 | ID NOW Influenza A & B 2OZE · Special | Alere Scarborough, Inc. | 03/18/2019SE |
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…OZE · Special | Centers For Disease Control and Prevention (CDC) | 07/30/2018SE |
| K171641 | Accula Flu A/Flu B TestOZE · Dual Track | Mesa Biotech, Inc. | 02/06/2018SE |
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Questions and answers
When was Lyra Influenza A+B Assay cleared by the FDA?
Lyra Influenza A+B Assay (K230236) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 32 days after the submission was received.
What is the product code of K230236?
The FDA product code is OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.