Cleared Traditional

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA (K071867) - FDA 510(k) Clearance

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

K071867 · Paragondx, LLC · Toxicology device
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Apr 2008
Decision
297d
Days
Class 2
Risk

K071867 is an FDA 510(k) clearance for the RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA. Classified as Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System (product code ODV), Class II - Special Controls.

Submitted by Paragondx, LLC (Morrisville, US). The FDA issued a Cleared decision on April 28, 2008 after a review of 297 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.7750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K071867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date April 28, 2008
Days to Decision 297 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 87d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODV Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
Definition An In Vitro Diagnostic Assay For Use In Genotyping Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Alleles To Aid In The Identification Of Patients At Risk For Altered Warfarin Sensitivity.
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.