← Product Code [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) · K962674

# STA - VWF CONTROL [N]+[P] KIT (K962674)

_American Bioproducts Co. · GGN · Jul 23, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K962674

## Device Facts

- **Applicant:** American Bioproducts Co.
- **Product Code:** [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN.md)
- **Decision Date:** Jul 23, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for 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.

## Regulatory 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](/device/K942117.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K962674](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K962674)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com