Cleared Traditional

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (K083052) - FDA 510(k) Clearance

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

K083052 · Euroimmun Us, Inc. · Immunology device
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Jul 2009
Decision
287d
Days
Class 2
Risk

K083052 is an FDA 510(k) clearance for the EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA). Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on July 28, 2009 after a review of 287 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Euroimmun Us, Inc. devices

Submission Details

510(k) Number K083052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date July 28, 2009
Days to Decision 287 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
183d slower than avg
Panel avg: 104d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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.