# K160164: BD Veritor System for Rapid Detection of Flu A + B Labratory Kit

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 25, 2016 after 29 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902609 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120049: BD Veritor System for the Rapid Detection of Flu a+B, Becton, Dickinson and Company (2012) Summary page 5.
- K121797: BD Veritor (TM) System for Rapid Detection of Flu a+B, Becton, Dickinson and Company (2012) Summary page 5.
- K132256: BD Veritor System for the Rapid Detection of Flu a+B, Becton, Dickinson and Company (2013) Summary page 5.
- K132693: BD Veritor™ System Flu A+B Assay, Becton, Dickinson and Company (2013) Summary page 5.
- K133138: BD Veritor™ System Flu A+B Assay, Becton, Dickinson & CO (2013) Summary page 5.
- K151301: BD Veritor™ System Flu A+B Assay, Becton, Dickinson and Company (2015) Summary page 5.
- K152874: BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit, Becton, Dickinson and Co. (2015) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K160164
Methodology: https://510kreport.com/methodology