Search Contact Legal Statement
Roche Index Site Map Link to www.roche-diagnostics.com
About us Product and services What's new Careers Press room Related linls

 


Accu-Chek® Advantage® Module System Receives 510(k) Clearance from FDA

New Module turns PDA into blood glucose meter and data management tool for people with diabetes

Indianapolis, Indiana - June 17, 2002 - Roche Diagnostics, the world's leader in in vitro diagnostics, just received 510(k) clearance from the U.S. Food and Drug Administration for its Accu-Chek® Advantage® Module System, a new blood glucose meter that fits into the expansion slots of several HandspringÔ Visor handheld computer models. A "powerful" tool for monitoring blood glucose levels, this new technology is designed to help people with diabetes better manage their disease.

"Roche is committed to providing innovative solutions that meet the needs of people with diabetes and make their lives easier. The module is Roche's newest innovation in diabetes technology," said Don Dumoulin, vice president of Diabetes Care Marketing at Roche Diagnostics. "The Accu-Chek Advantage Module System provides personal diabetes management in an easy-to-use product, right in the palm of their hand."

The Accu-Chek Advantage Module System uses Accu-Chek®Comfort Curve® Test Strips, which have a unique curved shape that fits the human finger for easy blood application utilizing capillary action and requiring only a small blood sample. Dumoulin gave other examples of Roche Diagnostics diabetes innovations, which include the module as well as Accu-Chek Compass™ and Accu-Chek Pocket Compass™ Diabetes Care Software, the Acculink® Modem, and the Accu-Chek Compact™ and Accu-Chek Active™ blood glucose monitoring systems, the only systems available that have infrared data transfer capability.

New Era in Blood Glucose Monitoring and Diabetes Management

The Accu-Chek Advantage Module System comes with the Accu-Chek Pocket Compass™ Diabetes Care Software, which installs when the module is inserted. After each reading, the software automatically stores the test results. This data helps people and their providers analyze and better understand blood glucose readings and tailor disease management regimens based on the trends they identify. Accu-Chek Pocket Compass Diabetes Care Software, which works on handheld computers running the Palm OS® Platform, is also available separately.

"Roche has changed the concept of diabetes management by linking its blood glucose monitoring technology to today's most popular and accessible technologies," Dumoulin said.

Accu-Chek blood glucose monitoring systems collect blood glucose data and can transfer data via infrared into the Accu-Chek Pocket Compass™ Diabetes Care Software or to a PC-based version. Accu-Chek products are designed to work together as a complete disease management system.

For more information about Accu-Chek products, call Accu-Chek Customer CareSM at 1-800-858-8072 or visit www.accu-chek.com.

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics, and vitamins. Roche's products and services address prevention, diagnosis, and treatment of diseases, thus enhancing well being and quality of life. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals, and laboratories worldwide. Roche Diagnostics Corporation, based in Indianapolis, is the North American headquarters for the diagnostics business of the company. Roche Diagnostics' website is located at www.roche-diagnostics.com.

Copyright © 2005 Roche Diagnostics, North America
All Rights Reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement