Cleared Traditional

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

K082118 · Cepheid · Pathology

Sep 2009

Decision

417d

Days

Class 2

Risk

About This 510(k) Submission

K082118 is an FDA 510(k) clearance for the XPERT HEMOSIL FACTOR II & FACTOR V ASSAY, a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPQ), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 18, 2009, 417 days after receiving the submission on July 28, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K082118 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2008
Decision Date	September 18, 2009
Days to Decision	417 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NPQ — Test, Factor V Leiden 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 V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.