Cleared Traditional

K882620 - APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM

K882620 is an FDA 510(k) clearance for APOLIPOPROTEIN FOR THE TECHNICON DPA-1(..., manufactured by Technicon Instruments Corp.. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K882620 · Technicon Instruments Corp. · Immunology device
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Jul 1988
Decision
14d
Days
Class 1
Risk

K882620 is an FDA 510(k) clearance for the APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 14 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K882620

510(k) Number K882620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date July 08, 1988
Days to Decision 14 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
91d faster than avg
Panel avg: 105d · This submission: 14d
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 K882620.
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1988
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
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · Atlantic Antibodies · Jun 1988
APOLIPOPROTEIN A1
K873863 · Unipath , Ltd. · Oct 1987
APOLIPOPROTEIN B
K873864 · Unipath , Ltd. · Oct 1987