Cleared Traditional

K850691 - ANTISERUM TO HUMAN APOLIPOPROTEIN A-I

K850691 is an FDA 510(k) clearance for ANTISERUM TO HUMAN APOLIPOPROTEIN A-I, manufactured by Kent Laboratories, Inc.. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K850691 · Kent Laboratories, Inc. · Immunology device
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Nov 1985
Decision
253d
Days
Class 1
Risk

K850691 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN APOLIPOPROTEIN A-I. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 253 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 Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K850691

510(k) Number K850691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date November 01, 1985
Days to Decision 253 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
148d slower than avg
Panel avg: 105d · This submission: 253d
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 K850691.
VENTREX APO B
K861919 · Ventrex Laboratories, Inc. · Jun 1986
BIOGRAM APO A1/B
K860629 · Bio-Rad · Mar 1986
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · Kent Laboratories, Inc. · Nov 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
K851641 · Ortho Diagnostic Systems, Inc. · Jul 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638 · Behring Diagnostics, Inc. · May 1985