Cleared Traditional

INVADER MTHFR 677 (K100987) - FDA 510(k) Clearance

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

K100987 · Hologic, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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.