Cleared Traditional

K873864 - APOLIPOPROTEIN B

K873864 is an FDA 510(k) clearance for APOLIPOPROTEIN B, manufactured by Unipath , Ltd.. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K873864 · Unipath , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
50d
Days
Class 1
Risk

K873864 is an FDA 510(k) clearance for the APOLIPOPROTEIN B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on October 13, 1987 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unipath , Ltd. devices

FDA 510(k) Submission Details - K873864

510(k) Number K873864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date October 13, 1987
Days to Decision 50 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
55d faster than avg
Panel avg: 105d · This submission: 50d
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 K873864.
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620 · Technicon Instruments Corp. · Jul 1988
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · Atlantic Antibodies · Jun 1988
APOLIPOPROTEIN A1
K873863 · 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
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K870564 · Atlantic Antibodies · Mar 1987