# ODW: Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

- Device class: 2; regulation: 21 CFR 862.3360; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 2007: 1
- 2008: 2
- 2009: 1
- 2016: 1
- 2019: 1

## Most-cited predicates
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument (2008), cited by 5
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin (2008), cited by 1
- K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test (2007), cited by 1

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