# NPQ: Test, Factor V Leiden Mutations, Genomic Dna Pcr

- Device class: 2; regulation: 21 CFR 864.7280; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 14 (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
- 2007: 1
- 2009: 1
- 2010: 2
- 2011: 1

## Most-cited predicates
- DEN030005: Factor V Leiden Kit (2003), cited by 5
- K060564: Infiniti System (2007), cited by 4
- K082118: Xpert Hemosil Factor II & Factor V Assay (2009), cited by 1

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