Cleared Traditional

K123713 - IMMULISA ENHANCED CELIAC FUSION (TTG/DG...

K123713 is an FDA 510(k) clearance for IMMULISA ENHANCED CELIAC FUSION (TTG/DG..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K123713 · Immco Diagnostics, Inc. · Immunology device
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Oct 2013
Decision
325d
Days
Class 2
Risk

K123713 is an FDA 510(k) clearance for the IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K123713

510(k) Number K123713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2012
Decision Date October 25, 2013
Days to Decision 325 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 104d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVM Device Classification - Class 2, Special Controls

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 Immunology devices follow this clearance model.

Regulatory Peers - MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 25
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K123713.
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