# K021789: Quicklab RSV

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Biotechnology Corp.
- Decided: Nov 20, 2002 after 173 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: 1 generation back to K882629 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882629: Directigen Respiratory Syncytial Virus Test Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 2.

## Indications for use
The QuickLab RSVTMTest is intended for the qualitative detection of Respiratory Syncytial Virus antigens (fusion protein) directly from nasopharyngeal swab, and nasal aspirate specimens in children less than 6 years and adults over the age of 60. The QuickLab RSV test is intended for use as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with symptoms consistent with an RSV infection. It is recommended that negative results be confirmed by cell culture.

Source page: https://510kreport.com/device/K021789
Methodology: https://510kreport.com/methodology