Cleared Traditional

K012386 - ACTICLOT PROTEIN S

K012386 is the FDA 510(k) clearance for ACTICLOT PROTEIN S by American Diagnostica, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K012386 · American Diagnostica, Inc. · Hematology device
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Sep 2001
Decision
49d
Days
Class 2
Risk

K012386 is an FDA 510(k) clearance for the ACTICLOT PROTEIN S, MODEL 843L. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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 American Diagnostica, Inc. devices

Submission Details

510(k) Number K012386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2001
Decision Date September 14, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 113d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K012386.
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · Instrumentation Laboratory CO · Apr 2004
MODIFICATION TO COATEST FACTOR VIII
K033631 · Instrumentation Laboratory CO · Dec 2003
PROTEIN S AC
K022290 · Dade Behring, Inc. · Aug 2002
IL TEST PROS
K011424 · Instrumentation Laboratory CO · Jun 2001
IL TEST FREE PROTEIN S
K010379 · Instrumentation Laboratory CO · Apr 2001
COALIZA PROTEIN S-FREE
K002467 · Instrumentation Laboratory CO · Oct 2000