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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.
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