# MCB: Antigen, C. Difficile

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 10
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1984: 1
- 1990: 1
- 1991: 1
- 1992: 1
- 1996: 1
- 1998: 1
- 2006: 1
- 2011: 2
- 2013: 1

## Most-cited predicates
- K053572: C. Diff Quik Chek (2006), cited by 3
- K974881: Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a (1998), cited by 2

Source page: https://510kreport.com/product-code/MCB
Data by year (CSV): https://510kreport.com/product-code/MCB.csv