# NPR: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

- Device class: 2; regulation: 21 CFR 864.7280; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 84 days (middle half 56–111)
- Recalls: 2 (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)
- 2003: 1
- 2011: 1
- 2018: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K033612: Factor II (Prothrombin) G20210A Kit (2003), cited by 5
- K223046: Xpert® FII & FV (2023), cited by 1

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