Cleared Traditional

K983289 - APOLIPOPROTEIN A1

K983289 is an FDA 510(k) clearance for APOLIPOPROTEIN A1, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DER cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K983289 · Abbott Laboratories · Immunology device
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Jan 1999
Decision
133d
Days
Class 2
Risk

K983289 is an FDA 510(k) clearance for the APOLIPOPROTEIN A1. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5580 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K983289

510(k) Number K983289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1998
Decision Date January 29, 1999
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 104d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DER Device Classification - Class 2, Special Controls

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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 - DER Alpha-1-lipoprotein, Antigen, Antiserum, Control

All 11
Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K983289.
K-ASSAY APO B
K993354 · Kamiya Biomedical Co. · Oct 1999
K-ASSAY APO AI
K993345 · Kamiya Biomedical Co. · Oct 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · Roche Diagnostics Corp. · Apr 1999
N-ASSAY TIA APO A1 TEST KIT
K964292 · Crestat Diagnostics, Inc. · Aug 1997
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · Crestat Diagnostics, Inc. · Aug 1997
N-ASSAY TIA APO B TEST KIT
K964296 · Crestat Diagnostics, Inc. · Aug 1997