# K951010: Chlamydia Oia

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Oct 7, 1995 after 215 days
- Product code: LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group))
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K023947: GC OIA (2003), 0 descendants of its own

## Recalls of this device
- Feb 7, 2003 · Not classified · Z-0616-03: Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
- Feb 7, 2003 · Not classified · Z-0615-03: Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

Source page: https://510kreport.com/device/K951010
Methodology: https://510kreport.com/methodology