Cleared Special

K200033 - HemosIL von Willebrand Factor Antigen

K200033 is an FDA 510(k) clearance for HemosIL von Willebrand Factor Antigen, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GGP cleared through the Special 510(k) pathway after a 225-day FDA review.

K200033 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
225d
Days
Class 2
Risk

K200033 is an FDA 510(k) clearance for the HemosIL von Willebrand Factor Antigen. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 19, 2020 after a review of 225 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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. Standard predicate reliance. 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 - K200033

510(k) Number K200033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2020
Decision Date August 19, 2020
Days to Decision 225 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
112d slower than avg
Panel avg: 113d · This submission: 225d
Pathway characteristics
Modification to existing cleared device.

GGP Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K200033.
vWF Ag
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HemosIL von Willebrand Factor Antigen
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CRYOcheck FVIII Inhibitor Kit
K183440 · Precision Biologic, Inc. · Mar 2019
INNOVANCE Free PS Ag
K181525 · Siemens Healthcare Diagnostics Products GmbH · Sep 2018
K200033 · HemosIL von Willebrand Factor Antigen
Download PDF FDA Summary Instrumentation Labor…