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U.S. Department of Health and Human Services

Product Classification
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Device von willebrand factor assay
Definition A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma.
Physical State VWF activity test system containing reagents, automated coagulometer, controls and calibrators
Technical Method The tests detect the binding of VWF to its receptor Glycoprotein Ib (GPIb) which induces a particle agglutination which can be measured as an increase in extinction by turbidimetric measurements.
Target Area Peripheral human whole blood (citrated plasma)
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeQTY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7293
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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