21 CFR 864.7293 — Von Willebrand Factor Assay

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7293

Identification

The INNOVANCE VWF Ac assay is an in-vitro diagnostic automated, particle-enhanced turbidimetric assay for the quantitative determination of von Willebrand factor (VWF)-GPIb-binding activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS XP System. It is intended as an aid in the evaluation of patients with suspected or confirmed von Willebrand factor disorders.

Classification Rationale

Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the identified risks.

Product Codes