# K991828: Strep B Oia

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Aug 19, 1999 after 83 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
Longest line of descent: 1 generation back to K936112 (1994). 1 ancestor in all.
18 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)
- K936112: Strep B Oia, Biostar, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX) (2012), 2 descendants of its own

## Indications for use
The BioStar® STREP B OIA® assay is an Optical InmunoAssay (OIA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.

Source page: https://510kreport.com/device/K991828
Methodology: https://510kreport.com/methodology