Cleared Traditional

K081674 - BINDAZYME HUMAN ANTI-GLIADIN (MGP)

Also marketed or referenced as:
BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT (IGA OR IGG)

K081674 is the FDA 510(k) clearance for BINDAZYME HUMAN ANTI-GLIADIN (MGP) by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code MST) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K081674 · The Binding Site, Ltd. · Immunology device
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Oct 2008
Decision
120d
Days
Class 2
Risk

K081674 is an FDA 510(k) clearance for the BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA 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 October 15, 2008 after a review of 120 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 K081674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date October 15, 2008
Days to Decision 120 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
16d slower than avg
Panel avg: 104d · This submission: 120d
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 K081674.
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
K113863 · Inova Diagnostics, Inc. · Sep 2012
QUANTA FLASH (TM) DGP SCREEN
K111414 · Inova Diagnostics, Inc. · Oct 2011
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · Immco Diagnostics, Inc. · Feb 2010
QUANTA LITE H-TTG/DGP SCREEN
K070083 · Inova Diagnostics, Inc. · Mar 2007
QUANTA LITE CELIAC DGP SCREEN
K062708 · Inova Diagnostics, Inc. · Dec 2006
QUANTA LITE GLIADIN IGG II
K052142 · Inova Diagnostics, Inc. · Oct 2005