Cleared Traditional

K983281 - APOB

K983281 is an FDA 510(k) clearance for APOB, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DFC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K983281 · Abbott Laboratories · Immunology device
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Jan 1999
Decision
130d
Days
Class 2
Risk

K983281 is an FDA 510(k) clearance for the APOB. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 26, 1999 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5600 - 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 - K983281

510(k) Number K983281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1998
Decision Date January 26, 1999
Days to Decision 130 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
26d slower than avg
Panel avg: 104d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K983281.
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · Roche Diagnostics Corp. · Apr 1999
SPQ TEST SYSTEM
K982708 · DiaSorin, Inc. · Apr 1999
WAKO AUTOKIT LP(A)
K981446 · Wako Chemicals USA, Inc. · Mar 1999
WAKO AUTOKIT APO B
K954657 · Wako Chemicals USA, Inc. · Dec 1995
IL TEST CALIBRATION SET APO A1B
K923079 · Instrumentation Laboratory CO · Feb 1993
EQUATE(TM) AQR APO AL/B DUO CONTROL
K903122 · Binax, Inc. · Aug 1990