Cleared Traditional

K200230 - Aptiva Celiac Disease IgG Reagent (FDA 510(k) Clearance)

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

K200230 · Inova Diagnostics, Inc. · Immunology device
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Aug 2021
Decision
574d
Days
Class 2
Risk

K200230 is an FDA 510(k) clearance for the Aptiva Celiac Disease IgG 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 August 26, 2021 after a review of 574 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 K200230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2020
Decision Date August 26, 2021
Days to Decision 574 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
470d slower than avg
Panel avg: 104d · This submission: 574d
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.