Cleared Special

Xpert? FII & FV

K223046 · Cepheid · Hematology

Feb 2023

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K223046 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 15, 2023, 139 days after receiving the submission on September 29, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K223046 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2022
Decision Date	February 15, 2023
Days to Decision	139 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.