Cleared Traditional

INFINITI SYSTEM

K060564 · AutoGenomics, Inc. · Pathology

Feb 2007

Decision

341d

Days

Class 2

Risk

About This 510(k) Submission

K060564 is an FDA 510(k) clearance for the INFINITI SYSTEM, a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPQ), submitted by AutoGenomics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 7, 2007, 341 days after receiving the submission on March 3, 2006. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K060564 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2006
Decision Date	February 07, 2007
Days to Decision	341 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.