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The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level, intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level. Each manufactured lot of STA®-vWF Calibrator is assigned a vWF value which is determined with an internal VWF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor established in 1992. Each STA®-vWF Calibrator kit provides 6 x 1-ml vials of citrated human plasma in freeze-dried form. The vWF value of each lot is provided in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board the STA® analyzer.

This document does not contain the information requested for acceptance criteria and study details.

The provided text is a summary for a 510(k) premarket notification for a medical device (STA®-vWF Calibrator Kit). It describes:

• The device's intended use: A calibrator for von Willebrand Factor (vWF) antigen assays.
• How the vWF value is assigned: Against an internal reference calibrated to an international standard.
• Kit contents and stability: 6 x 1-ml vials, freeze-dried, 24 months stability at 2°-8°C, 4 hours on board the analyzer after reconstitution.

It does not include any performance data, acceptance criteria, study methodologies, or details about ground truth establishment, sample sizes, or expert involvement. These types of details are typically found in a clinical study report or a more extensive section on performance characteristics, neither of which is present here.

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