Cleared Traditional

K990204 - GLIADIN IGG ELISA TEST SYSTEM

K990204 is an FDA 510(k) clearance for GLIADIN IGG ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K990204 · Zeus Scientific, Inc. · Immunology device
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Mar 1999
Decision
64d
Days
Class 2
Risk

K990204 is an FDA 510(k) clearance for the GLIADIN IGG ELISA TEST SYSTEM. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 26, 1999 after a review of 64 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K990204

510(k) Number K990204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date March 26, 1999
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 104d · This submission: 64d
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 22
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K990204.
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · Cogent Diagnotics , Ltd. · Nov 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250 · Zeus Scientific, Inc. · Nov 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · Zeus Scientific, Inc. · Mar 1999
BINDAZYME ANTIGLIADIN IGG
K981644 · The Binding Site, Ltd. · Sep 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · The Binding Site, Ltd. · Sep 1998