Cleared Traditional

K864228 - APO B.

K864228 is the FDA 510(k) clearance for APO B. by Intl. Diagnostic Laboratories, Ltd.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K864228 · Intl. Diagnostic Laboratories, Ltd. · Immunology device
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Mar 1987
Decision
135d
Days
Class 1
Risk

K864228 is an FDA 510(k) clearance for the APO B., IMMUNOTURBIDIMETRIC ASSAY. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Intl. Diagnostic Laboratories, Ltd. (Israel, IL). The FDA issued a Cleared decision on March 12, 1987 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 Intl. Diagnostic Laboratories, Ltd. devices

Submission Details

510(k) Number K864228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 12, 1987
Days to Decision 135 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 104d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - MSJ Apolipoproteins

All 31
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K864228.
APOLIPOPROTEIN B
K873864 · Unipath , Ltd. · Oct 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · Medix Biotech, Inc. · Sep 1987
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079 · Reagents Applications, Inc. · Jun 1987
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019 · Beckman Instruments, Inc. · Jul 1986
ICS APOLIPOPROTEIN B REAGENT TEST KIT
K862386 · Beckman Instruments, Inc. · Jul 1986
VENTREX APO B
K861919 · Ventrex Laboratories, Inc. · Jun 1986