STA-VWF CALIBRATOR KIT

K962671 · American Bioproducts Co. · GJT · Sep 13, 1996 · Hematology

Device Facts

• Record ID: K962671
• Device Name: STA-VWF CALIBRATOR KIT
• Applicant: American Bioproducts Co.
• Product Code: GJT · Hematology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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).

Device Story

STA®-vWF Calibrator consists of freeze-dried citrated human plasma containing normal levels of von Willebrand Factor (vWF). Used in clinical laboratory settings by trained technicians to calibrate immuno-turbidimetric vWF antigen assays on the STA® analyzer. Each lot is assigned a vWF value via internal reference calibrated against the 3rd International Standard 91/666. Provided in 6 x 1-ml vials; requires reconstitution. Stability: 24 months at 2-8°C; 4 hours on-board analyzer. Output is a reference value used to establish calibration curves for patient sample testing, ensuring accurate quantification of vWF antigen levels.

Clinical Evidence

Bench testing only; calibration values established via traceability to the 3rd International Standard 91/666.

Technological Characteristics

Citrated human plasma; freeze-dried form; immuno-turbidimetric assay calibration; stored 2-8°C; 4-hour on-board stability.

Indications for Use

Indicated for use as a calibration plasma for the immuno-turbidimetric assay of von Willebrand Factor (vWF) antigen on the STA® analyzer.

Reference Devices

• STA® analyzer (K942117)
• 3rd International Standard 91/666 for Factor VIII and von Willebrand Factor

Submission Summary (Full Text)

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SEP 13 1996
K962671
Page 16 of 16

AMERICAN BIOPRODUCTS COMPANY
Premarket 510(k) Notification
STA®-vWF Calibrator Kit

## VII. SAFETY AND EFFECTIVENESS SUMMARY

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).

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.