# OZN: C. Difficile Toxin Gene Amplification Assay

- Device class: 2; regulation: 21 CFR 866.3130; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 106 days (middle half 85–146)
- Recalls: 3 (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)
- 2012: 2
- 2013: 4
- 2014: 1
- 2015: 1
- 2017: 5
- 2021: 2
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K130470: BD Max Cdiff Assay, BD Max Instrument (2013), cited by 4
- K171770: cobas Cdiff Nucleic acid test for use on the cobas Liat System (2017), cited by 2
- K123998: Quidel Molecular Direct C. Difficile Assay (2013), cited by 2
- K212427: cobas Cdiff nucleic acid test for use on the cobas Liat System (2021), cited by 2
- K123355: Amplivue C. Difficile Assay (2012), cited by 1
- K172569: GenePOC CDiff (2017), cited by 1
- K142422: cobas Cdiff Test (2015), cited by 1

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