Cleared Traditional

K042644 - AESKULISA TTG A AND AESKULISA TTG G

K042644 is an FDA 510(k) clearance for AESKULISA TTG A AND AESKULISA TTG G, manufactured by Aesku, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K042644 · Aesku, Inc. · Immunology device
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Jun 2005
Decision
247d
Days
Class 2
Risk

K042644 is an FDA 510(k) clearance for the AESKULISA TTG A AND AESKULISA TTG G. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Aesku, Inc. (Miami, US). The FDA issued a Cleared decision on June 1, 2005 after a review of 247 days - an extended review cycle.

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. Standard predicate reliance. 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 Aesku, Inc. devices

FDA 510(k) Submission Details - K042644

510(k) Number K042644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date June 01, 2005
Days to Decision 247 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 105d · This submission: 247d
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 28
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K042644.
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · Phadia US, Inc. · Dec 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · Phadia US, Inc. · Dec 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · Immco Diagnostics, Inc. · May 2006
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · Immco Diagnostics, Inc. · Dec 2003
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566 · Inova Diagnostics, Inc. · Jul 2001