# K964887: Vidas C. Difficile Toxin a II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Apr 8, 1997 after 123 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.
No later device cites it as a predicate yet.
0 of 1 device 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 C. difficile Toxin A test: named in the summary without a submission number

## Indications for use
The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A.

Source page: https://510kreport.com/device/K964887
Methodology: https://510kreport.com/methodology