Cleared Traditional

K100987 - INVADER MTHFR 677

K100987 is an FDA 510(k) clearance for INVADER MTHFR 677, manufactured by Hologic, Inc.. The device is a Class 2 Pathology device with product code OMM cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K100987 · Hologic, Inc. · Pathology device
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May 2011
Decision
399d
Days
Class 2
Risk

K100987 is an FDA 510(k) clearance for the INVADER MTHFR 677. Classified as Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr (product code OMM), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 399 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Hologic, Inc. devices

FDA 510(k) Submission Details - K100987

510(k) Number K100987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2010
Decision Date May 13, 2011
Days to Decision 399 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 77d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMM Device Classification - Class 2, Special Controls

Product Code OMM Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7280
Definition In Vitro Diagnostic For The Detection And Genotyping Of A Single Point Mutation Of The Human 5, 10-methylenetetrahydrofolate Reductase Gene (mthfr) In 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.