STA - VWF CONTROL [N]+[P] KIT

K962674 · American Bioproducts Co. · GGN · Jul 23, 1996 · Hematology

Device Facts

• Record ID: K962674
• Device Name: STA - VWF CONTROL [N]+[P] KIT
• Applicant: American Bioproducts Co.
• Product Code: GGN · Hematology
• Decision Date: Jul 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The STA®-vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

Device Story

Kit contains freeze-dried citrated human plasma; normal and abnormal vWF levels; used as quality control for immuno-turbidimetric vWF antigen assays; performed on STA® analyzer; values assigned via internal reference calibrated to 3rd International Standard 91/666; provides 12 vials each of normal and abnormal control; stable 24 months freeze-dried at 2-8°C; stable 8 hours post-reconstitution on-board analyzer; assists clinicians in verifying assay performance.

Clinical Evidence

Bench testing only; values assigned via internal reference assayed against 3rd International Standard 91/666 for Factor VIII and von Willebrand Factor.

Technological Characteristics

Freeze-dried citrated human plasma; immuno-turbidimetric assay control; 12 x 1-ml vials per level; stored 2-8°C; reconstituted with water; stable 8 hours on-board STA® analyzer.

Indications for Use

Indicated for use as normal and abnormal quality control material for von Willebrand Factor (vWF) antigen assays in clinical laboratory settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Reference Devices

• STA® analyzer (K942117)

Submission Summary (Full Text)

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JUL 23 1996
K 962674
AMERICAN BIOPRODUCTS COMPANY
Premarket 510(k) Notification
STA®-vWF Control [N]+[P] Kit
Page 16 of 16

# VII. SAFETY AND EFFECTIVENESS SUMMARY

The STA®-vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

Each manufactured lot of STA®-vWF Control [N]+[P] is assigned vWF values (normal and abnormal levels) which are 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 Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA®-vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board the STA® analyzer.