# OMN: C. Difficile Nucleic Acid Amplification Test Assay

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 5
- Recalls: 1 (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)
- 2010: 1
- 2011: 2
- 2012: 1

## Most-cited predicates
- DEN120013: C. Difficile Nucleic Acid Amplification Test Assay (), cited by 4
- K100818: Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920 (2010), cited by 1
- K110012: Illumigene C. Difficile, and Illumipro-10 (2011), cited by 1
- K110203: Xpert C. Difficle/Epi Assay (2011), cited by 1

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