STA - LIATEST VWF TEST KIT

K962675 · American Bioproducts Co. · GJT · Oct 25, 1996 · Hematology

Device Facts

• Record ID: K962675
• Device Name: STA - LIATEST VWF TEST KIT
• Applicant: American Bioproducts Co.
• Product Code: GJT · Hematology
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

The STA®-Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.

Device Story

In vitro diagnostic test kit; performs quantitative assay of vWF antigen in citrated plasma. Uses immuno-turbidimetric method; input is citrated plasma sample; reagent consists of microlatex particles coated with rabbit anti-human vWF antibodies. Device operates on STA® analyzer; measures light absorbance of latex particle suspension. Output is quantitative vWF antigen level. Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing or monitoring conditions related to vWF levels.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance characteristics of the immuno-turbidimetric assay compared to the predicate electro-immunodiffusion method.

Technological Characteristics

Immuno-turbidimetric assay; utilizes microlatex particles coated with rabbit anti-human vWF antibodies. Reagents include glycine buffer and diluent. Designed for use on STA® analyzer; measures light absorbance. Storage 2-8°C; 18-month shelf life; 15-day on-board stability.

Indications for Use

Indicated for quantitative determination of von Willebrand Factor (vWF) antigen levels in citrated plasma for patients requiring assessment of vWF levels.

Predicate Devices

• ASSERA®-PLATE vWF kit (K861417)

Submission Summary (Full Text)

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K962675

AMERICAN BIOPRODUCTS COMPANY

Premarket 510(k) Notification

STA®-Liatest® vWF Test Kit

OCT 25 1996

Page 31 of 31

# VIII. Safety and Effectiveness Summary

The STA®-Liatest® vWF test kit is intended for use with the STA® analyzer to perform quantitative assays of von Willebrand Factor (vWF) antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific anti-vWF antibodies.

Each STA®-Liatest® vWF test kit provides: 4 x 5-ml vials of ready-for-use glycine buffer; 4 x 2-ml vials of a suspension of microlatex particles coated with rabbit anti-human vWF antibodies; 4 x 4-ml vials of diluent solution containing glycine for dilution of the latex reagent before use.

Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials or after dilution, kit reagents are stable for 15 days on board the STA® analyzer.

The proposed STA®-Liatest® vWF test kit has demonstrated substantial equivalence to the commercially available ASSERA®-PLATE vWF kit (Diagnostica Stago, France; K861417) which is an electro-immunodiffusion procedure for the quantitative determination of vWF antigen levels in citrated plasma.