# K854852: Wellcogen Bacterial Antigen Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wellcome Diagnostics
- Decided: Feb 4, 1986 after 61 days
- Product code: GTJ (Antisera, All Groups, N. Meningitidis)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K012521: Binax Now Streptococcus Pneumoniae Test (2001), 1 descendant of its own
- K991726: Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni (1999), 1 descendant of its own
- K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K854852
Methodology: https://510kreport.com/methodology