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Xpert FII & FV

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250218

by Cepheid

Identifiers

510(k) Number
K250218 FDA 510(k)
FDA Product Code
NPR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7280 FDA 510(k)
Regulation Number
864.7280 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Xpert FII & FV is a qualitative in vitro diagnostic genotyping test for the simultaneous detection of Factor II (G20210A) and Factor V Leiden (G1691A) mutations in genomic DNA. It identifies specific point mutations associated with thrombophilia risk by amplifying and analyzing target sequences via polymerase chain reaction (PCR).

The test is designed for use on the Cepheid GeneXpert Instrument Systems and requires sodium citrate or EDTA anticoagulated whole blood as the sample input. It is intended for laboratory use only and is classified as a Class II device under FDA regulations (K250218, NPR). Results are generated within approximately 30 minutes, enabling rapid diagnostic support for hematology evaluations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Xpert® FII & FV - Cepheid, Xpert® FII & FV - Detail - cepheid.com, PDF Xpert® Factor II & Factor V - web-support.cepheid.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cepheid

Sources (1)

  • FDA 510(k) K250218 24 fields · synced Sep 19, 2026