510(k) · Cleared
ClearedBD Veritor™ System Flu A+B Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jun 8, 2015 as substantially equivalent to K120049 (Becton, Dickinson and Company, 2012) and 4 other predicates after a 24-day review. Its family tree reaches back 10 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 8, 2015
- Review
- 24 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K902609 (1990). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 6 generations between
- 3 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 2 generations backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 1 generation backK133138 BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO · 2013
- This deviceK151301 BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company · 2015
- Descendant · cites it directly · 1 of its ownK152874 BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co. · 2015
- Descendant · cites it directly · 0 of its ownK160164 BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
Show all 10 generations
- Root · 10 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 9 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 8 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 7 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 6 generations backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- 5 generations backK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- 4 generations backK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- 3 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 2 generations backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 1 generation backK133138 BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO · 2013
- This deviceK151301 BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −9 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −8 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −7 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −6 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| −5 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| −4 | 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 | — |
| −2 | K132692 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| −1 | K133138 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson & CO | 2013 | — |
| 0 (this device) | K151301 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson and Company | 2015 | — |
| +1 | K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | Becton, Dickinson and Co. | 2015 | — |
| +1 | K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | Becton, Dickinson & CO | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K120049 | BD Veritor System for the Rapid Detection of Flu a+BSummary page 4…TE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit (K120049,K121797,K132256,K132693,K133138) INTENDED USE : Laboratory Kit The BD Veritor™ System for Rapid Detection of Flu A+B is a rapi… | 2012 |
| * | K121797 | BD Veritor (TM) System for Rapid Detection of Flu a+BSummary page 4…ES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit (K120049,K121797,K132256,K132693,K133138) INTENDED USE : Laboratory Kit The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chroma… | 2012 |
| * | K132256 | BD Veritor System for the Rapid Detection of Flu a+BSummary page 4…BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit (K120049,K121797,K132256,K132693,K133138) INTENDED USE : Laboratory Kit The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographi… | 2013 |
| * | K132693 | BD Veritor™ System Flu A+B AssaySummary page 4…BD Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit (K120049,K121797,K132256,K132693,K133138) INTENDED USE : Laboratory Kit The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immuno… | 2013 |
| * | K133138 | BD Veritor™ System Flu A+B AssaySummary page 4…Veritor™ System for Rapid Detection of Flu A+B Laboratory Kit (K120049,K121797,K132256,K132693,K133138) INTENDED USE : Laboratory Kit The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay fo… | 2013 |
What descends from it? (2)
2 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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K152874 (Becton, Dickinson and Co., 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K120049.
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. 2015, 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 BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash, aspirate and swab in transport media samples from symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a…
Read the full statement (411 words)
The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and
qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash, aspirate and swab in
transport media samples from symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B is a
differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single
processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral
infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an
FDA-cleared influenza A and B molecular assay. Outside the U.S. a negative test is presumptive and it is recommended
that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA
has not cleared this device outside the U.S. Negative test results do not preclude influenza viral infection and should not
be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza
C antigens.
Performance characteristics for influenza A and B nasopharyngeal (NP) washes/aspirates were established during January
through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were
the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC
entitled “Update: Influenza Activity—United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza
Vaccine.” Performance characteristics may vary against other emerging influenza viruses.
Performance characteristics for influenza A and B NP swabs in transport media were established during January through
April of 2012 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the
predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC
entitled “Update: Influenza Activity—United States, 2011-2012 Season, and Composition of the 2012-2013 Influenza
Vaccine.” Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza 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 the state or local health department for testing. Virus culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151301: BD Veritor™ System Flu 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/K151301
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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