Cleared Traditional

K162540 - INNOVANCE(r) Heparin Reagents

K162540 is an FDA 510(k) clearance for INNOVANCE(r) Heparin Reagents, manufactured by Siemens Healthcare Diagnostics Prodcts GmbH. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K162540 · Siemens Healthcare Diagnostics Prodcts GmbH · Hematology device
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Aug 2017
Decision
344d
Days
Class 2
Risk

K162540 is an FDA 510(k) clearance for the INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) .... Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Prodcts GmbH (Marburg, DE). The FDA issued a Cleared decision on August 22, 2017 after a review of 344 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 Siemens Healthcare Diagnostics Prodcts GmbH devices

FDA 510(k) Submission Details - K162540

510(k) Number K162540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date August 22, 2017
Days to Decision 344 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
231d slower than avg
Panel avg: 113d · This submission: 344d
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 30
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K162540.
HemosIL Liquid Anti-Xa
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K090209 · Instrumentation Laboratory CO · Jun 2009
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
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · Medical Diagnostic Technologies, Inc. · Aug 1997