Cleared Traditional

K900124 - APOLIPOPROTEIN B (APO B)

K900124 is an FDA 510(k) clearance for APOLIPOPROTEIN B (APO B), manufactured by Sigma Chemical Co.. The device is a Class 1 Immunology device with product code DEL cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K900124 · Sigma Chemical Co. · Immunology device
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Mar 1990
Decision
52d
Days
Class 1
Risk

K900124 is an FDA 510(k) clearance for the APOLIPOPROTEIN B (APO B). Classified as Lipoprotein X, Antigen, Antiserum, Control (product code DEL), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 2, 1990 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5590 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K900124

510(k) Number K900124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date March 02, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 105d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

DEL Device Classification - Class 1, General Controls

Product Code DEL Lipoprotein X, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5590
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DEL Lipoprotein X, Antigen, Antiserum, Control

Devices cleared under the same product code (DEL) and FDA review panel - the closest regulatory comparables to K900124.
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · Roche Diagnostics Corp. · Nov 2001
APOLIPOPROTEIN A-I (APO A-I)
K901675 · Sigma Chemical Co. · Apr 1990
ORTHO *APO A-1 ELISA TEST SYSTEM
K895160 · Medical Marketing Consultants, Inc. · Oct 1989
BACTON TM, BASIC TM, APO A-I REAGENT
K893885 · Catachem, Inc. · Jun 1989
K900124 · APOLIPOPROTEIN B (APO B)
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