# K250218: Xpert® FII & FV

- Pathway: 510(k) (Special)
- Applicant: Cepheid
- Decided: Feb 21, 2025 after 28 days
- Product code: NPR (Test, Factor Ii G20210a 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: 3 generations back to DEN030005 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223046: Xpert® FII & FV, Cepheid® (2023) Summary page 5.

## Indications for use
The Xpert® FII & FV test is a qualitative in vitro diagnostic genotyping test for the detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the GeneXpert® Instrument Systems. This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

Source page: https://510kreport.com/device/K250218
Methodology: https://510kreport.com/methodology