# K072138: Vidas C. Difficile Toxin a&B (Cdab) Assay, Model: 30 118

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 21, 2007 after 141 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
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. The FDA summary names its predicate without a number.
- (no number) Meridian Premier Toxins A&B: named in the summary without a submission number

## Most influential descendants
- K080931: Vidas C. Dificile Toxin a & B (Cdab) Assay (2008), 0 descendants of its own

## 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).

Source page: https://510kreport.com/device/K072138
Methodology: https://510kreport.com/methodology