510(k) · Cleared
ClearedQuickvue Influenza a+B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Sep 15, 2009 as substantially equivalent to K031899 (Quidel Corp., 2003) and 1 other predicate after a 13-day review. Its family tree reaches back 5 generations to 1990. 24 later devices descend from it.
- Decided
- Sep 15, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902609 (1990). 7 ancestors in all. 24 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 4 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 3 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 2 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 1 generation backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- This deviceK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- Descendant · cites it directly · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- Descendant · 2 generations on · 19 of its ownK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- Descendant · 2 generations on · 17 of its ownK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- Descendant · 2 generations on · 11 of its ownK151291 BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015
- Descendant · 2 generations on · 10 of its ownK152870 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co. · 2015
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · cites it directly20descendants
- K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 2 generations on19descendants
- K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 2 generations on17descendants
- K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015 · 2 generations on11descendants
- K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co. · 2015 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −4 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −3 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −2 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −1 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| 0 (this device) | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| +1 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
| +2 | K132259 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| +2 | K132692 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| +2 | K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015 | — |
| +2 | K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson and Co. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 PSZ? 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 PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K031899 | Quickvue Influenza a+B TestSummary page 1…r 1, 2009 Device Trade Name: QuickVue® Influenza A+B Common Name: Influenza Test Predicate Device: QuickVue Influenza A+B (K031899 and K053146) Product Code: GNX Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological… | 2003 |
| * | K053146 | Quickvue Influenza a + B TestSummary page 1…evice Trade Name: QuickVue® Influenza A+B Common Name: Influenza Test Predicate Device: QuickVue Influenza A+B (K031899 and K053146) Product Code: GNX Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological… | 2005 |
What descends from it? (24)
See all 243 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K112277 (Becton, Dickinson and Company, 2011) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K031899.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092698: Quickvue Influenza a+B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092698
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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