Cleared Traditional

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B (K861882) - FDA 510(k) Clearance

Class I Immunology device.

K861882 · Orion Corp. · Immunology device
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Oct 1986
Decision
167d
Days
Class 1
Risk

K861882 is an FDA 510(k) clearance for the IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 29, 1986 after a review of 167 days - an extended review cycle.

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 Orion Corp. devices

Submission Details

510(k) Number K861882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1986
Decision Date October 29, 1986
Days to Decision 167 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 104d · This submission: 167d
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 13
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K861882.
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · Roche Diagnostic Systems, Inc. · May 1991
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · Technicon Instruments Corp. · Sep 1988
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620 · Technicon Instruments Corp. · Jul 1988
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
BIOGRAM APO A1/B
K860629 · Bio-Rad · Mar 1986