# LLH: Reagents, Clostridium Difficile Toxin

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 42
- 510(k) review time 2021–2025: median 569 days (middle half 569–569)
- Recalls: 8 (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)
- 1999: 3
- 2000: 1
- 2003: 3
- 2004: 4
- 2005: 1
- 2007: 1
- 2008: 2
- 2009: 3
- 2010: 1
- 2021: 1

## Most-cited predicates
- K081920: BD Geneohm Cdiff Assay (2008), cited by 5
- K003306: C. Difficile Tox a/B II (2000), cited by 4
- K041003: Immunocard Toxins a & B, Model 712050 (2004), cited by 3
- K993914: Premier Toxins a&B, Model 616096 (1999), cited by 3
- K030992: C. Diff Chek - 60 (2003), cited by 3
- K935296: Clostridium Difficile Tox-B Test (1994), cited by 3
- K041951: Xpect Clostridium Difficile Toxin a/B (2004), cited by 3
- K923463: Clostridium Difficile Toxin/Antitoxin Kit (1993), cited by 3
- K870864: Culturette Brand CDT Clostridium Difficile Test (1987), cited by 2
- K971182: Tox a/B Test (1997), cited by 2

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