# DEN030005: Factor V Leiden Kit

- Pathway: De Novo (Post-NSE)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 17, 2003 after 9 days
- Product code: NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr)
- Device class: 2
- Regulation: 21 CFR 864.7280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), 3 descendants of its own
- K082118: Xpert Hemosil Factor II & Factor V Assay (2009), 2 descendants of its own
- K223046: Xpert® FII & FV (2023), 1 descendant of its own
- K250218: Xpert® FII & FV (2025), 0 descendants of its own
- K172913: cobas Factor II and Factor V Test (2018), 0 descendants of its own

Source page: https://510kreport.com/device/DEN030005
Methodology: https://510kreport.com/methodology