# K936112: Strep B Oia

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Jul 6, 1994 after 195 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991828: Strep B Oia (1999), 18 descendants of its own
- K022504: Idi-Strep B Assay (2002), 17 descendants of its own
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B (2006), 14 descendants of its own
- K112125: Illumigene Group B Streptococcus ,External Control Kit (2011), 4 descendants of its own
- K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab (2010), 4 descendants of its own

Source page: https://510kreport.com/device/K936112
Methodology: https://510kreport.com/methodology