# K133140: BD Veritor System for the Rapid Detection of RSV

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 15, 2013 after 29 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902609 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 1.
- K121797: BD Veritor (TM) System for Rapid Detection of Flu a+B, Becton, Dickinson and Company (2012) Summary page 1.
- K132256: BD Veritor System for the Rapid Detection of Flu a+B, Becton, Dickinson and Company (2013) Summary page 1.
- K132692: BD Veritor System for the Rapid Detection of Flu a+B, Becton, Dickinson and Company (2013) Summary page 1.

## Indications for use
The IBD VoritorM System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV antigen from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV Infections in neonatal and pediatric patients under the age of 20. Negative results do not preclude RSV Infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD VertorTM System Reader.

Source page: https://510kreport.com/device/K133140
Methodology: https://510kreport.com/methodology