Cleared Traditional

K013305 - ENOXAPARIN TEST CARD

K013305 is an FDA 510(k) clearance for ENOXAPARIN TEST CARD, manufactured by Cardiovascular Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K013305 · Cardiovascular Diagnostics, Inc. · Hematology device
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Aug 2002
Decision
323d
Days
Class 2
Risk

K013305 is an FDA 510(k) clearance for the ENOXAPARIN TEST CARD. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 23, 2002 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cardiovascular Diagnostics, Inc. devices

FDA 510(k) Submission Details - K013305

510(k) Number K013305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date August 23, 2002
Days to Decision 323 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
210d slower than avg
Panel avg: 113d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFF Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K013305.
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
K111822 · Diagnostica Stago, Inc. · Oct 2011
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · Instrumentation Laboratory CO · Jun 2009
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
K050367 · Hyphen Biomed · May 2006
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · International Technidyne Corp. · Jun 2001
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998