Cleared Traditional

K983694 - ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT

K983694 is an FDA 510(k) clearance for ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOST..., manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K983694 · The Binding Site, Ltd. · Immunology device
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Feb 1999
Decision
107d
Days
Class 2
Risk

K983694 is an FDA 510(k) clearance for the ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 5, 1999 after a review of 107 days - within the typical 510(k) review window.

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. 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

FDA 510(k) Submission Details - K983694

510(k) Number K983694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date February 05, 1999
Days to Decision 107 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
2d slower than avg
Panel avg: 105d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
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 - MID System, Test, Anticardiolipin Immunological

All 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K983694.
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
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ACL/APS FACS KIT
K984102 · Louisville Apl Diagnostics, Inc. · Mar 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · The Binding Site, Ltd. · Feb 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695 · The Binding Site, Ltd. · Feb 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
K983696 · The Binding Site, Ltd. · Feb 1999
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173 · Zeus Scientific, Inc. · Dec 1998