# K955859: Immunocard Toxin a

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Apr 18, 1996 after 113 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) Tissue culture cytotoxin assay with neutralization using specific anti-toxin: named in the summary without a submission number

## Indications for use
The ImmunoCard Toxin A enzyme immunoassay (EIA) is a rapid in vitro qualitative procedure for detecting Clostridium difficile toxin A in human stool. The test can be used to aid in the diagnosis of C. difficile-associated disease. The test may also be used to determine the production of toxin A by C. difficile in BHI broth culture.

Source page: https://510kreport.com/device/K955859
Methodology: https://510kreport.com/methodology