Cleared Traditional

K193604 - Aptiva Celiac Disease IgA Reagent

K193604 is the FDA 510(k) clearance for Aptiva Celiac Disease IgA Reagent by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MVM) cleared through the Traditional 510(k) pathway after a 541-day FDA review.

K193604 · Inova Diagnostics, Inc. · Immunology device
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Jun 2021
Decision
541d
Days
Class 2
Risk

K193604 is an FDA 510(k) clearance for the Aptiva Celiac Disease IgA Reagent. 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 June 16, 2021 after a review of 541 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K193604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date June 16, 2021
Days to Decision 541 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 104d · This submission: 541d
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 22
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K193604.
Aptiva Celiac Disease IgG Reagent
K200230 · Inova Diagnostics, Inc. · Aug 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
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · Immco Diagnostics, Inc. · Oct 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053 · Bio-Rad Laboratories, Inc. · Sep 2013
QUANTA FLASH H-TTG IGG
K101644 · Inova Diagnostics, Inc. · Mar 2011