Cleared Traditional

K002189 - GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

K002189 is an FDA 510(k) clearance for GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM, manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K002189 · Scimedx Corp. · Immunology device
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Oct 2000
Decision
92d
Days
Class 2
Risk

K002189 is an FDA 510(k) clearance for the GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 92 days - within the typical 510(k) review window.

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 Scimedx Corp. devices

FDA 510(k) Submission Details - K002189

510(k) Number K002189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2000
Decision Date October 19, 2000
Days to Decision 92 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
13d faster than avg
Panel avg: 105d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MST Antibodies, Gliadin

All 34
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K002189.
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354 · Sweden Diagnostics (Germany) GmbH · Jul 2004
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K001393 · Zeus Scientific, Inc. · Jun 2000
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · Cogent Diagnotics , Ltd. · Nov 1999