Cleared Traditional

QUANTA FLASH H-TTG IGG (K101644) - FDA 510(k) Clearance

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

K101644 · Inova Diagnostics, Inc. · Immunology device
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Mar 2011
Decision
286d
Days
Class 2
Risk

K101644 is an FDA 510(k) clearance for the QUANTA FLASH H-TTG IGG. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 23, 2011 after a review of 286 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K101644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date March 23, 2011
Days to Decision 286 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
182d slower than avg
Panel avg: 104d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K101644.
Aptiva Celiac Disease IgG Reagent
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Aptiva Celiac Disease IgA Reagent
K193604 · Inova Diagnostics, Inc. · Jun 2021
EliA Celikey IgG Immunoassay
K181871 · Phadia AB · Mar 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313 · Euroimmun Us, Inc. · Feb 2019