Cleared Traditional

K993087 - AUTOSTAT II ANTI-GLIADIN IGG ELISA

K993087 is the FDA 510(k) clearance for AUTOSTAT II ANTI-GLIADIN IGG ELISA by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code MST) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K993087 · Cogent Diagnotics , Ltd. · Immunology device
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Nov 1999
Decision
58d
Days
Class 2
Risk

K993087 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GLIADIN IGG ELISA. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on November 12, 1999 after a review of 58 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 Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K993087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1999
Decision Date November 12, 1999
Days to Decision 58 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
46d faster than avg
Panel avg: 104d · This submission: 58d
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.

Regulatory Peers - MST Antibodies, Gliadin

All 22
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K993087.
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
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250 · Zeus Scientific, Inc. · Nov 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204 · Zeus Scientific, Inc. · Mar 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · Zeus Scientific, Inc. · Mar 1999