Cleared Special

K133005 - HEMOSIL VON WILLEBRAND ACTIVITY ASSAY

K133005 is the FDA 510(k) clearance for HEMOSIL VON WILLEBRAND ACTIVITY ASSAY by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Special 510(k) pathway after a 169-day FDA review.

K133005 · Instrumentation Laboratory CO · Hematology device
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Mar 2014
Decision
169d
Days
Class 2
Risk

K133005 is an FDA 510(k) clearance for the HEMOSIL VON WILLEBRAND ACTIVITY ASSAY. 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 March 13, 2014 after a review of 169 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K133005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date March 13, 2014
Days to Decision 169 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 113d · This submission: 169d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 113
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