Cleared Traditional

ACTICHROME HEPARIN (ANTI-FIIA) (K013637) - FDA 510(k) Clearance

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

K013637 · American Diagnostica, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 2002
Decision
162d
Days
Class 2
Risk

K013637 is an FDA 510(k) clearance for the ACTICHROME HEPARIN (ANTI-FIIA). Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on April 16, 2002 after a review of 162 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Diagnostica, Inc. devices

Submission Details

510(k) Number K013637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date April 16, 2002
Days to Decision 162 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
49d slower than avg
Panel avg: 113d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 45
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K013637.
HemosIL Liquid Anti-Xa
K213464 · Instrumentation Laboratory CO · Oct 2022
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · Instrumentation Laboratory CO · Jun 2009
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994