# K902609: Directigen Flu a

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Sep 10, 1990 after 90 days
- Product code: GNT (Antigens, Ha (Including Ha Control), Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 1 cites it directly.
0 of 47 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
- K981651: AB Flu Oia (1998), 45 descendants of its own
- K023556: Flu Oia a/B Test Kit (2003), 40 descendants of its own
- K031899: Quickvue Influenza a+B Test (2003), 34 descendants of its own
- K053146: Quickvue Influenza a + B Test (2005), 27 descendants of its own
- K092698: Quickvue Influenza a+B Test (2009), 24 descendants of its own

Source page: https://510kreport.com/device/K902609
Methodology: https://510kreport.com/methodology