Cleared Traditional

K981929 - BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT

K981929 is the FDA 510(k) clearance for BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code MST) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K981929 · The Binding Site, Ltd. · Immunology device
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Sep 1998
Decision
118d
Days
Class 2
Risk

K981929 is an FDA 510(k) clearance for the BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 3, 1998 after a review of 118 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K981929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date September 03, 1998
Days to Decision 118 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
14d slower than avg
Panel avg: 104d · This submission: 118d
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 20
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K981929.
GLIADIN IGG ELISA TEST SYSTEM
K990204 · Zeus Scientific, Inc. · Mar 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · Zeus Scientific, Inc. · Mar 1999
BINDAZYME ANTIGLIADIN IGG
K981644 · The Binding Site, Ltd. · Sep 1998
QUANTA LITE IGA GLIADIN ELISA
K964986 · Inova Diagnostics, Inc. · Jun 1997
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
K964341 · Immco Diagnostics, Inc. · May 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344 · Immco Diagnostics, Inc. · May 1997