# K974881: Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Mar 20, 1998 after 80 days
- Product code: MCB (Antigen, C. Difficile)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053572: C. Diff Quik Chek (2006), 3 descendants of its own
- K132010: Vidas C Difficile GDH (2013), 0 descendants of its own
- K112048: Immunocard C. Difficile GDH (2011), 0 descendants of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Recalls of this device
- Dec 4, 2007 · Not classified · Z-1352-2008: False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

## Indications for use
The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.

Source page: https://510kreport.com/device/K974881
Methodology: https://510kreport.com/methodology