Cleared Traditional

K864228 - APO B., IMMUNOTURBIDIMETRIC ASSAY

K864228 is an FDA 510(k) clearance for APO B., manufactured by Intl. Diagnostic Laboratories, Ltd.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K864228

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
30d slower than avg
Panel avg: 105d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

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 38
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K864228.
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079 · Reagents Applications, Inc. · Jun 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K870564 · Atlantic Antibodies · Mar 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K870862 · Atlantic Antibodies · Mar 1987
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K861882 · Orion Corp. · Oct 1986
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
K861883 · Orion Corp. · Oct 1986
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019 · Beckman Instruments, Inc. · Jul 1986