Cleared Special

K213464 - HemosIL Liquid Anti-Xa

K213464 is an FDA 510(k) clearance for HemosIL Liquid Anti-Xa, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code KFF cleared through the Special 510(k) pathway after a 341-day FDA review.

K213464 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
341d
Days
Class 2
Risk

K213464 is an FDA 510(k) clearance for the HemosIL Liquid Anti-Xa. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 4, 2022 after a review of 341 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213464

510(k) Number K213464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2021
Decision Date October 04, 2022
Days to Decision 341 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 113d · This submission: 341d
Pathway characteristics
Modification to existing cleared device.

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 46
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K213464.
STA® - Liquid Anti-Xa
K260214 · Diagnostica Stago, Inc. · Sep 2026
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
K162540 · Siemens Healthcare Diagnostics Prodcts GmbH · Aug 2017
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
ENOXAPARIN TEST CARD
K013305 · Cardiovascular Diagnostics, Inc. · Aug 2002
K213464 · HemosIL Liquid Anti-Xa
Download PDF FDA Summary Instrumentation Labor…