510(k) · Cleared
Recalled · Class II · 2022BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Mar 20, 2018 as substantially equivalent to K112277 (Becton, Dickinson and Company, 2011) and 4 other predicates after a 28-day review. Its family tree reaches back 12 generations to 1990. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 12 generations to K902609 (1990). 14 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 8 generations between
- 3 generations backK151291 BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015
- 2 generations backK152870 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co. · 2015
- 1 generation backK160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
- This deviceK180438 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd · 2018
- Descendant · cites it directly · 2 of its ownK223016 BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd · 2023
- Descendant · 2 generations on · 1 of its ownK232434 BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd · 2023
- Descendant · cites it directly · 1 of its ownK191514 CareStart Flu A&B PlusAccess Bio, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK252283 Nano-Check Influenza A+B TestNano-Ditech Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK250398 Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
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 backK151291 BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015
- 2 generations backK152870 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co. · 2015
- 1 generation backK160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
- This deviceK180438 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd · 2018
Most influential descendants
Showing 5 of 5 · See all- K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd · 2023 · cites it directly2descendants
- K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd · 2023 · 2 generations on1descendant
- K191514CareStart Flu A&B PlusAccess Bio, Inc. · 2020 · cites it directly1descendant
- K252283Nano-Check Influenza A+B TestNano-Ditech Corporation · 2026 · 3 generations on0descendants
- K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025 · 2 generations on0descendants
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 | 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 | — |
| −1 | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson & CO | 2016 | — |
| 0 (this device) | K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd | 2018 | — |
| +1 | K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | Bd | 2023 | — |
| +2 | K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit | Bd | 2023 | — |
| +1 | K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020 | — |
| +3 | K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026 | — |
| +2 | K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+BSummary page 4…Microbiology PREDICATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit (k112277, k132259, k132692, k151291, k160161) INTENDED USE : The BD Veritor System for Rapid Detection… | 2011 |
| * | K132259 | BD Veritor System for the Rapid Detection of Flu a+BSummary page 4…Microbiology PREDICATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit (k112277, k132259, k132692, k151291, k160161) INTENDED USE : The BD Veritor System for Rapid Detection of Flu A… | 2013 |
| * | K132692 | BD Veritor System for the Rapid Detection of Flu a+BSummary page 4…Microbiology PREDICATE DEVICES : BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit (k112277, k132259, k132692, k151291, k160161) INTENDED USE : The BD Veritor System for Rapid Detection of Flu A+B CLIA w… | 2013 |
| * | K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+BSummary page 4…BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit (k112277, k132259, k132692, k151291, k160161) INTENDED USE : The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immu… | 2015 |
| * | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitSummary page 4…D Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit (k112277, k132259, k132692, k151291, k160161) INTENDED USE : The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay f… | 2016 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2022 | Class II | Z-0630-2022 | Under Investigation by firm | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. |
| Apr 3, 2019 | Class II | Z-1313-2019 | Under Investigation by firm | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K223016 (Bd, 2023) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K112277.
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. 2018, 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 nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished…
Read the full statement (348 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 nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System 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 for use outside of 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 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.
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/K180438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180438: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180438
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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