510(k) · Cleared
ClearedLyra Influenza A+B Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Cleared on Mar 3, 2023 as substantially equivalent to K131728 (Quidel Corp., 2013) after a 32-day review. Its family tree reaches back 6 generations to 2008.
- Decided
- Mar 3, 2023
- Review
- 32 days
- Class
- Class II
- Product code
- OZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN070013 (2008). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 4 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 3 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 2 generations backK112172 Quidel Molecular Influenza a + B AssayQuidel Corp. · 2011
- 1 generation backK131728 Quidel Molecular Influenza a + B AssayQuidel Corp. · 2013
- This deviceK230236 Lyra Influenza A+B AssayQuidel Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −5 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −4 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −3 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −2 | K112172 | Quidel Molecular Influenza a + B Assay | Quidel Corp. | 2011 | — |
| −1 | K131728 | Quidel Molecular Influenza a + B Assay | Quidel Corp. | 2013 | — |
| 0 (this device) | K230236 | Lyra Influenza A+B Assay | Quidel Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OZE device
- #1 K243274 CDC Human Influenza Virus Real-Time RT-PCR…score 16.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131728 | Quidel Molecular Influenza a + B AssaySummary page 4…emistry Acid Amplification 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 Nucli… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K131728.
How does its category compare?
All OZE devicesOZE Influenza A And Influenza B Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OZE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZE
43in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZE
No recall names OZE since 2007.
Adverse event reports per year · OZE
2in 2025
MAUDE reports naming product code OZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 22 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 43 | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (240 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230236: Lyra Influenza A+B Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230236
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026