Cleared Traditional

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

K093129 · Illumina, Inc. · Pathology

Apr 2010

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K093129 is an FDA 510(k) clearance for the ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II, a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPQ), submitted by Illumina, Inc. (San Diego, US). The FDA issued a Cleared decision on April 28, 2010, 208 days after receiving the submission on October 2, 2009. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K093129 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2009
Decision Date	April 28, 2010
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement

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.