# K882629: Directigen Respiratory Syncytial Virus Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Oct 31, 1988 after 126 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
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022133: BD Directigen EZ RSV Kit (2002), 11 descendants of its own
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 (2003), 9 descendants of its own
- K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 (2006), 6 descendants of its own
- K070747: Quick Vue RSV Test, Models 20193, 20199 (2007), 5 descendants of its own
- K101918: Quickvue RSV 10 (2010), 4 descendants of its own

Source page: https://510kreport.com/device/K882629
Methodology: https://510kreport.com/methodology