# K112277: BD Veritor (TM) System for Rapid Detection of Flu a+B

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 28, 2011 after 80 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902609 (1990). 8 ancestors in all.
20 later devices descend from it; 8 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053146: Quickvue Influenza a + B Test, Quidel Corp. (2005) Summary page 3.
- K092698: Quickvue Influenza a+B Test, Quidel Corp. (2009) Summary page 3.

## Most influential descendants
- K132259: BD Veritor System for the Rapid Detection of Flu a+B (2013), 19 descendants of its own
- K132692: BD Veritor System for the Rapid Detection of Flu a+B (2013), 17 descendants of its own
- 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

## Recalls of this device
- Apr 3, 2019 · Class II · Z-1314-2019: 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 inappropria

## Indications for use
The BD VeritorM 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 and nasal swabs of 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. 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 HiNi, A/H3N2, B/Victoria lineage, and B/Yamnagata 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.

Source page: https://510kreport.com/device/K112277
Methodology: https://510kreport.com/methodology