Cleared Traditional

K093974 - ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING (FDA 510(k) Clearance)

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

K093974 · Osmetech Molecular Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
120d
Days
Class 2
Risk

K093974 is an FDA 510(k) clearance for the ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FI.... Classified as Test, Factor V Leiden Mutations, Genomic Dna Pcr (product code NPQ), Class II - Special Controls.

Submitted by Osmetech Molecular Diagnostics (Pasadena, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 120 days - within the typical 510(k) review window.

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 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osmetech Molecular Diagnostics devices

Submission Details

510(k) Number K093974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2009
Decision Date April 22, 2010
Days to Decision 120 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 77d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.