Cleared Traditional

K881898 - MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIP...

K881898 is the FDA 510(k) clearance for MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIP... by Atlantic Antibodies. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K881898 · Atlantic Antibodies · Immunology device
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Jun 1988
Decision
47d
Days
Class 1
Risk

K881898 is an FDA 510(k) clearance for the MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on June 14, 1988 after a review of 47 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 Atlantic Antibodies devices

Submission Details

510(k) Number K881898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date June 14, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 104d · This submission: 47d
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 31
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K881898.
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
APOLIPOPROTEIN A1
K873863 · Unipath , Ltd. · Oct 1987
APOLIPOPROTEIN B
K873864 · Unipath , Ltd. · Oct 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · Medix Biotech, Inc. · Sep 1987