Cleared Traditional

K903531 - ANTICARDIOLIPIN ANTIBODY TEST SYSTEM

K903531 is an FDA 510(k) clearance for ANTICARDIOLIPIN ANTIBODY TEST SYSTEM, manufactured by Medical Innovations Corp.. The device is a Class 2 Immunology device with product code GFO cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K903531 · Medical Innovations Corp. · Immunology device
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Jan 1991
Decision
172d
Days
Class 2
Risk

K903531 is an FDA 510(k) clearance for the ANTICARDIOLIPIN ANTIBODY TEST SYSTEM. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Medical Innovations Corp. (Portland, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 172 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.7925 - 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 Medical Innovations Corp. devices

FDA 510(k) Submission Details - K903531

510(k) Number K903531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1990
Decision Date January 25, 1991
Days to Decision 172 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
67d slower than avg
Panel avg: 105d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K903531.
ELLAGIC ACID APTT REAGENT
K915418 · Helena Laboratories · Feb 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · International Technidyne Corp. · Feb 1992
HEMOCHRON(R) APTT, MODIFICATION
K911994 · International Technidyne Corp. · Jul 1991
THE THERATEST ACA TEST
K905301 · Theratest Laboratories, Inc. · Jan 1991
APTT REAGENT
K904341 · Sigma Chemical Co. · Nov 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K902556 · Analytical Control Systems, Inc. · Aug 1990