Cleared Traditional

K132978 - IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST (FDA 510(k) Clearance)

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

K132978 · Sequenom, Inc. · Pathology device
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Jun 2014
Decision
263d
Days
Class 2
Risk

K132978 is an FDA 510(k) clearance for the IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST. Classified as System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations (product code PHJ), Class II - Special Controls.

Submitted by Sequenom, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 2014 after a review of 263 days - an extended review cycle.

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 Sequenom, Inc. devices

Submission Details

510(k) Number K132978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2013
Decision Date June 13, 2014
Days to Decision 263 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
186d slower than avg
Panel avg: 77d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHJ System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7280
Definition A Multiplex Genotying Test System Intended For The Qualitative Detection And Identification Of Specific Thrombophilia Related Gene Mutations From Genomic Dna By Genomic Amplification And Mass Spectrometry. It Is Intended As An Aid In Diagnosis 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.