Cleared Traditional

K883713 - QM300 APOLIPOPROTEIN A-I ANTIBODY PACK

K883713 is an FDA 510(k) clearance for QM300 APOLIPOPROTEIN A-I ANTIBODY PACK, manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. 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.

K883713 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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Oct 1988
Decision
50d
Days
Class 1
Risk

K883713 is an FDA 510(k) clearance for the QM300 APOLIPOPROTEIN A-I ANTIBODY PACK. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on October 19, 1988 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

FDA 510(k) Submission Details - K883713

510(k) Number K883713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1988
Decision Date October 19, 1988
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 K883713.
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · Roche Diagnostic Systems, Inc. · May 1991
BACTON TM, BASIC TM, APO B REAGENT
K893884 · Catachem, Inc. · Jun 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154 · Atlantic Antibodies · Mar 1989
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
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