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 24, 1999 after a 135-day review. The FDA summary names its predicate without a number. 46 later devices descend from it.
- Decided
- Sep 24, 1999
- Review
- 135 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 4 citing it directly.
- This deviceK991633 Quickvue Influenza a/B TestQuidel Corp. · 1999
- Descendant · cites it directly · 34 of its ownK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- Descendant · cites it directly · 27 of its ownK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- Descendant · 2 generations on · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- Descendant · 2 generations on · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- Descendant · 3 generations on · 19 of its ownK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K031899Quickvue Influenza a+B TestQuidel Corp. · 2003 · cites it directly34descendants
- K053146Quickvue Influenza a + B TestQuidel Corp. · 2005 · cites it directly27descendants
- K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · 2 generations on24descendants
- K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · 2 generations on20descendants
- K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991633 | Quickvue Influenza a/B Test | Quidel Corp. | 1999 | — |
| +1 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| +1 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| +2 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| +2 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
| +3 | K132259 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 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? (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 |
|---|---|---|---|
| * | — | viral culture Named without a submission number |
What descends from it? (46)
See all 464 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031899 | Quickvue Influenza a+B Test | 2003 | 34 |
| K053146 | Quickvue Influenza a + B Test | 2005 | 27 |
| K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack | 2002 | 11 |
| K021646 | Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack | 2002 | 7 |
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?
- Of its descendants, K031899 (Quidel Corp., 2003) has gone furthest, with 34 descendants of its own.
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.
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 is intended for the qualitative detection of influenza Type A and Type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The QuickVue Influenza A/B Test is intended for laboratory and professional use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991633: 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/K991633
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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