510(k) · Cleared
ClearedBD Veritor System for Rapid Detection of Flu A + B Labratory Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Feb 25, 2016 as substantially equivalent to K120049 (Becton, Dickinson and Company, 2012) and 6 other predicates after a 29-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Feb 25, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K902609 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 8 generations between
- 3 generations backK133138 BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO · 2013
- 2 generations backK151301 BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company · 2015
- 1 generation backK152874 BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co. · 2015
- This deviceK160164 BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
Show all 12 generations
- Root · 12 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 11 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 10 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 9 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 8 generations backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- 7 generations backK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- 6 generations backK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- 5 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 4 generations backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 3 generations backK133138 BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO · 2013
- 2 generations backK151301 BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company · 2015
- 1 generation backK152874 BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co. · 2015
- This deviceK160164 BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −11 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −10 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −9 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −8 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| −7 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| −6 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
| −5 | K132259 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| −4 | K132692 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| −3 | K133138 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson & CO | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (7)
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 5…GNX PREDICATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Labo… | 2012 |
| * | K121797 | BD Veritor (TM) System for Rapid Detection of Flu a+BSummary page 5…X PREDICATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Us… | 2012 |
| * | K132256 | BD Veritor System for the Rapid Detection of Flu a+BSummary page 5…ATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Use The BD… | 2013 |
| * | K132693 | BD Veritor™ System Flu A+B AssaySummary page 5…ES : BD Veritor™ System for Rapid Detection of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Use The BD Veritor™… | 2013 |
| * | K133138 | BD Veritor™ System Flu A+B AssaySummary page 5…apid Detection of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Use The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chroma… | 2013 |
| * | K151301 | BD Veritor™ System Flu A+B AssaySummary page 5…ction of Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Use The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic… | 2015 |
| * | K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitSummary page 5…Flu A+B Laboratory kit (k120049, k121797, k132256, k132693, k133138, k151301, k152874) INTENDED USE : Kit for Laboratory Use The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoas… | 2015 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 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. 2016, 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/K160164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160164: BD Veritor System for Rapid Detection of Flu A + B Labratory Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160164
Report an extraction error
Are you the manufacturer?
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