Cleared Traditional

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (K082118) - FDA 510(k) Clearance

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

K082118 · Cepheid · Pathology device
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Sep 2009
Decision
417d
Days
Class 2
Risk

K082118 is an FDA 510(k) clearance for the XPERT HEMOSIL FACTOR II & FACTOR V ASSAY. Classified as Test, Factor V Leiden Mutations, Genomic Dna Pcr (product code NPQ), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Pathology submissions.

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Submission Details

510(k) Number K082118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date September 18, 2009
Days to Decision 417 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 77d · This submission: 417d
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.