Cleared Traditional

K984619 - BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

K984619 is an FDA 510(k) clearance for BINDING SITE BINDAZYME ANTI-GBM EIA DIA..., manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code MVJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K984619 · The Binding Site, Ltd. · Immunology device
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Feb 1999
Decision
56d
Days
Class 2
Risk

K984619 is an FDA 510(k) clearance for the BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT. Classified as Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (product code MVJ), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 23, 1999 after a review of 56 days - a notably fast clearance cycle.

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: 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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K984619

510(k) Number K984619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1998
Decision Date February 23, 1999
Days to Decision 56 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
49d faster than avg
Panel avg: 105d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVJ Device Classification - Class 2, Special Controls

Product Code MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
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 - MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)

Devices cleared under the same product code (MVJ) and FDA review panel - the closest regulatory comparables to K984619.
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219 · Zeus Scientific, Inc. · Dec 2007
BIOPLEX VASCULITIS KIT
K072358 · Bio-Rad Laboratories · Oct 2007
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · Cogent Diagnotics , Ltd. · Aug 1999
QUANTA LITE GBM ELISA
K984336 · Inova Diagnostics, Inc. · Feb 1999