Cleared Traditional

K021398 - APL IGA ELISA KIT

K021398 is an FDA 510(k) clearance for APL IGA ELISA 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 117-day FDA review.

K021398 · Louisville Apl Diagnostics, Inc. · Immunology device
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Aug 2002
Decision
117d
Days
Class 2
Risk

K021398 is an FDA 510(k) clearance for the APL IGA ELISA 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 August 27, 2002 after a review of 117 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.

FDA 510(k) Submission Details - K021398

510(k) Number K021398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date August 27, 2002
Days to Decision 117 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
12d slower than avg
Panel avg: 105d · This submission: 117d
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 93
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K021398.
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
K023433 · Pharmacia Diagnostics GmbH & Co. KG · Nov 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · Corgenix, Inc. · Sep 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · Corgenix, Inc. · Sep 2002
QACA IGG/IGM ELISA KIT HRP
K021192 · Cheshire Diagnostics , Ltd. · May 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · Pharmacia Deutschland GmbH · May 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · Pharmacia Deutschland GmbH · May 2002
K021398 · APL IGA ELISA KIT
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