# K023947: GC OIA

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Biostar, Inc.
- Decided: Apr 17, 2003 after 141 days
- Product code: LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae)
- 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
Longest line of descent: 1 generation back to K951010 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951010: Chlamydia Oia, Biostar, Inc. (1995) Summary page 1.

## Indications for use
The Thermo BioSta@ GC OIA assay is an Optical ImmunoAssay test for the rapid qualitative detec:tion of gonococcal antigen (L7/L12 ribosomal protein) in female endocervical swab and male urine specimens. Urine specimens must be prepared using an accessory Urine Filtration Device (UFD) for concentration and extraction. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Neisseria gonoiprhoeae antigen. The assay is intended for use with symptomatic females and males, in populations at risk for sexually transmitted diseases.

Source page: https://510kreport.com/device/K023947
Methodology: https://510kreport.com/methodology