Cleared Traditional

K861919 - VENTREX APO B

K861919 is the FDA 510(k) clearance for VENTREX APO B by Ventrex Laboratories, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K861919 · Ventrex Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
18d
Days
Class 1
Risk

K861919 is an FDA 510(k) clearance for the VENTREX APO B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 18 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K861919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1986
Decision Date June 06, 1986
Days to Decision 18 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
86d faster than avg
Panel avg: 104d · This submission: 18d
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 30
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K861919.
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
BIOGRAM APO A1/B
K860629 · Bio-Rad · Mar 1986
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · Kent Laboratories, Inc. · Nov 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · Kent Laboratories, Inc. · Nov 1985