# K080931: Vidas C. Dificile Toxin a & B (Cdab) Assay

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 11, 2008 after 70 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 K072138 (2007). 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)
- K072138: Vidas C. Difficile Toxin a&B (Cdab) Assay, Model: 30 118, bioMerieux, Inc. (2007) Summary page 1.

## Indications for use
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Flurorescent Assay). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).

Source page: https://510kreport.com/device/K080931
Methodology: https://510kreport.com/methodology