Cleared Traditional

K923080 - IL TEST APOLIPOROTEIN B (APO B)

K923080 is an FDA 510(k) clearance for IL TEST APOLIPOROTEIN B (APO B), manufactured by Instrumentation Laboratory CO. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K923080 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
123d
Days
Class 1
Risk

K923080 is an FDA 510(k) clearance for the IL TEST APOLIPOROTEIN B (APO B). Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 123 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K923080

510(k) Number K923080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date October 26, 1992
Days to Decision 123 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
18d slower than avg
Panel avg: 105d · This submission: 123d
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 36
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K923080.
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · Beckman Instruments, Inc. · Apr 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
K964010 · Beckman Instruments, Inc. · Feb 1997
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992
APOLIPOPROTEIN TEST SYSTEM
K921037 · Baxter Diagnostics, Inc. · May 1992
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · Medical Analysis Systems, Inc. · Oct 1991