Cleared Abbreviated

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (K073014) - FDA 510(k) Clearance

Class II Toxicology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K073014 · Autogenomics, Incorporated · Toxicology device
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Jan 2008
Decision
90d
Days
Class 2
Risk

K073014 is an FDA 510(k) clearance for the INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN. Classified as Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (product code ODW), Class II - Special Controls.

Submitted by Autogenomics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on January 23, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3360 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Autogenomics, Incorporated devices

Submission Details

510(k) Number K073014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date January 23, 2008
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ODW Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3360
Definition An In Vitro Diagnostic Assay For Use In Genotyping Cytochrome P450 2c9 (cyp450 2c9) Alleles. Information About The Cyp2c9 Genotype May Be Used As An Aid To Clinicians In Determining Therapeutic Strategy For Medications That Are Metabolized By The Cyp2c9 Gene Product.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.