Cleared Traditional

EQ-PRC LC WARFARIN GENOTYPING KIT (K073071) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073071 · Trimgen Corporation · Toxicology device
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Feb 2009
Decision
464d
Days
Class 2
Risk

K073071 is an FDA 510(k) clearance for the EQ-PRC LC WARFARIN GENOTYPING KIT. Classified as Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (product code ODW), Class II - Special Controls.

Submitted by Trimgen Corporation (Sparks, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3360 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

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Submission Details

510(k) Number K073071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2007
Decision Date February 06, 2009
Days to Decision 464 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
377d slower than avg
Panel avg: 87d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.