Not Cleared Post-NSE

DEN030005 - FACTOR V LEIDEN KIT

DEN030005 is an FDA 510(k) submission for FACTOR V LEIDEN KIT, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Pathology device with product code NPQ cleared through the Post-NSE 510(k) pathway after a 9-day FDA review.

DEN030005 · Roche Diagnostics Corp. · Pathology device
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Dec 2003
Decision
9d
Days
Class 2
Risk

DEN030005 is an FDA 510(k) submission (not cleared) for the FACTOR V LEIDEN KIT. Classified as Test, Factor V Leiden Mutations, Genomic Dna Pcr (product code NPQ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on December 17, 2003 after a review of 9 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.7280 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

FDA 510(k) Submission Details - DEN030005

510(k) Number DEN030005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 08, 2003
Decision Date December 17, 2003
Days to Decision 9 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 78d · This submission: 9d
Pathway characteristics

NPQ Device Classification - Class 2, Special Controls

Product Code NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class Class 2 - 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.
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 Pathology devices follow this clearance model.

DEN030005 · FACTOR V LEIDEN KIT
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