Cleared Traditional

K973910 - GLIADIN ANTIBODIES ELISA

K973910 is an FDA 510(k) clearance for GLIADIN ANTIBODIES ELISA, manufactured by Genesis Diagnostics , Ltd.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 491-day FDA review.

K973910 · Genesis Diagnostics , Ltd. · Immunology device
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Feb 1999
Decision
491d
Days
Class 2
Risk

K973910 is an FDA 510(k) clearance for the GLIADIN ANTIBODIES ELISA. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Genesis Diagnostics , Ltd. (Littleport, Cambridgeshire, GB). The FDA issued a Cleared decision on February 17, 1999 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Genesis Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K973910

510(k) Number K973910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date February 17, 1999
Days to Decision 491 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
386d slower than avg
Panel avg: 105d · This submission: 491d
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 33
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K973910.
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
UNICAP GLIADIN IGA ASSAY
K982533 · Pharmacia & Upjohn Co. · Oct 1998
UNICAP GLIADIN IGG ASSAY
K982701 · Pharmacia & Upjohn Co. · Oct 1998
BINDAZYME ANTIGLIADIN IGG
K981644 · The Binding Site, Ltd. · Sep 1998