# K132692: BD Veritor System for the Rapid Detection of Flu a+B

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 23, 2013 after 25 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: 8 generations back to K902609 (1990). 10 ancestors in all.
17 later devices descend from it; 7 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112277: BD Veritor (TM) System for Rapid Detection of Flu a+B, Becton, Dickinson and Company (2011) Summary page 1.
- K132259: BD Veritor System for the Rapid Detection of Flu a+B, Becton, Dickinson and Company (2013). Our reading of the summary gave K132239, FDA’s number for Comprehensive Reverse Shoulder Screws (Biomet Manufacturing Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BD Veritor System for Rapid Detection of Flu A+B POC kit”.

## Most influential descendants
- K151291: BD Veritor (TM) System for the Rapid Detection of Flu A+B (2015), 11 descendants of its own
- K152870: BD Veritor System  for the Rapid Detection of Flu A + B CLIA waived kit (2015), 10 descendants of its own
- K160161: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (2016), 9 descendants of its own
- K180438: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (2018), 5 descendants of its own
- K133138: BD Veritor™ System Flu A+B Assay (2013), 3 descendants of its own

## Indications for use
The BD Veritor m System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and 8 viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BID Veritor System for Rapid Detection of Flu A+B3 (also referred to as the SID 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 isto be used as an aid inthe 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. 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 Aand B were established during January through March of 2011 when influenza viruses A/2009 HiNi, A/H3N2, S/Victoria lineage, and 5/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Modtality 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 far 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/K132692
Methodology: https://510kreport.com/methodology