# K991829: Cdtox a Oia

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Nov 2, 1999 after 158 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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 K903456 (1990). 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)
- K903456: Premier-C. Difficile Toxin a, Meridian Diagnostics, Inc. (1990) Summary page 1.

## Indications for use
The BioStar® CdTOX A OIA assay is an Optical ImmunoAssay test for the rapid qualitative detection of Clostridium difficile Toxin A in human fecal samples from patients suspected of having Clostridium difficile associated disease (CDAD). This test is intended for in vitro diagnostic use as an aid in the diagnosis of CDAD.

Source page: https://510kreport.com/device/K991829
Methodology: https://510kreport.com/methodology