# K082118: Xpert Hemosil Factor II & Factor V Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Sep 18, 2009 after 417 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
Longest line of descent: 1 generation back to DEN030005 (2003). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033612: Factor II (Prothrombin) G20210A Kit, Roche Diagnostics Corp. (2003) Summary page 1.
- DEN030005: Factor V Leiden Kit, Roche Diagnostics Corp. (2003). Our reading of the summary gave K033607, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN030005, Factor V Leiden Kit (Roche Diagnostics Corp.), granted Dec 17, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K223046: Xpert® FII & FV (2023), 1 descendant of its own
- K250218: Xpert® FII & FV (2025), 0 descendants of its own

## Indications for use
The Xpert TM HemosIL® Factor II & Factor V Assay is a qualitative in vitro diagnostic genotyping test for the rapid detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the Cepheid GeneXpert® Dx System. This test is intended to provide rapid results for Factor II (G20210A) and Factor V (Leiden) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

Source page: https://510kreport.com/device/K082118
Methodology: https://510kreport.com/methodology