# K122718: BD Veritor (TM) System for Rapid Detection of Group a Strep

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 6, 2013 after 154 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992658 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091489: Clearview Advanced Strep a , Model 737-430, Binax, Inc. (2009) Summary page 2.

## Indications for use
The BID Veritor TM System for Rapid Detection of Group A Strep test is a rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients. It is intended to be used in conjunction with the BID Veritor' System Reader as an aid in the diagnosis of Group A Strep. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The BID Veritor System for rapid detection of Group A Strep test is intended for use in point-of-care or laboratory settings.

Source page: https://510kreport.com/device/K122718
Methodology: https://510kreport.com/methodology