Cleared Traditional

K984102 - ACL/APS FACS KIT

K984102 is an FDA 510(k) clearance for ACL/APS FACS KIT, manufactured by Louisville Apl Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K984102 · Louisville Apl Diagnostics, Inc. · Immunology device
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Mar 1999
Decision
121d
Days
Class 2
Risk

K984102 is an FDA 510(k) clearance for the ACL/APS FACS KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Louisville Apl Diagnostics, Inc. (Doraville, US). The FDA issued a Cleared decision on March 18, 1999 after a review of 121 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 Louisville Apl Diagnostics, Inc. devices

FDA 510(k) Submission Details - K984102

510(k) Number K984102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date March 18, 1999
Days to Decision 121 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: 105d · This submission: 121d
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 K984102.
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · Cogent Diagnotics , Ltd. · Feb 2000
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · Cogent Diagnotics , Ltd. · Sep 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · The Binding Site, Ltd. · Feb 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694 · The Binding Site, Ltd. · Feb 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695 · The Binding Site, Ltd. · Feb 1999