Cleared Traditional

K903531 - ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 104d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.