Cleared Traditional

K991802 - BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT

K991802 is an FDA 510(k) clearance for BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K991802 · The Binding Site, Ltd. · Immunology device
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May 2000
Decision
345d
Days
Class 2
Risk

K991802 is an FDA 510(k) clearance for the BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on May 5, 2000 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K991802

510(k) Number K991802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date May 05, 2000
Days to Decision 345 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
240d slower than avg
Panel avg: 105d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSV Device Classification - Class 2, Special Controls

Product Code MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 35
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K991802.
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · Corgenix, Inc. · Sep 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · Corgenix, Inc. · Sep 2001
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · The Binding Site, Ltd. · May 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803 · The Binding Site, Ltd. · May 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804 · The Binding Site, Ltd. · May 2000
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · Hemagen Diagnostics, Inc. · Aug 1999