Cleared Traditional

K002358 - MDI GLIADIN A TEST

K002358 is an FDA 510(k) clearance for MDI GLIADIN A TEST, manufactured by Micro Detect, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K002358 · Micro Detect, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Oct 2000
Decision
78d
Days
Class 2
Risk

K002358 is an FDA 510(k) clearance for the MDI GLIADIN A TEST. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Detect, Inc. devices

FDA 510(k) Submission Details - K002358

510(k) Number K002358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2000
Decision Date October 19, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 105d · This submission: 78d
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 30
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K002358.
QUANTA LITE GLIADIN IGA II
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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