Cleared Special

Xpert? FII & FV

K250218 · Cepheid · Hematology
Feb 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K250218 is an FDA 510(k) clearance for the Xpert? FII & FV, a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPR), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 21, 2025, 28 days after receiving the submission on January 24, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number K250218 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2025
Decision Date February 21, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7280
Definition In Vitro Diagnostic Test To Detect The Factor Ii G20210a Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.