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ARKRAY, Inc. Receives FDA 510k Clearance on the Assure(R) Platinum Auto-Code Blood Glucose Monitoring System

EDINA, Minn., Dec. 10 /PRNewswire/ -- ARKRAY, Inc., the world's 5th largest manufacturer of diabetes self-monitoring systems, today received FDA clearance on the new Assure Platinum Blood Glucose Monitoring System.

The Assure Platinum Blood Glucose Monitoring System is the first auto-code Assure brand blood glucose meter. Assure meters are uniquely designed for long term care and multi-resident use settings. The new Assure Platinum is feature loaded and helps facilities meet state regulatory standards and provide better resident care. Auto-coding eliminates the need for any other form of manual coding, which can reduces user error thus ensuring more consistent, accurate results.

ARKRAY's commitment to accuracy is evident in the Assure Platinum Blood Glucose Monitoring System; the new system exceeds the new heightened standards the FDA has proposed. All ARKRAY Assure Blood Glucose Monitoring Systems utilize a glucose oxidase (GO) strip chemistry, and therefore are not subject to interferences than can affect GDH-PQQ systems. The FDA believes these interferences can cause falsely high results in person with diabetes using peritoneal dialysis solutions that contain icodextrin or maltose.

Assure Blood Glucose Meters are backed by the Assure® Brilliance program - a comprehensive service program from the leaders of diabetes management in long term care. Assure Brilliance provides customer service, on-site training, QA/QC guidance, diabetes F-Tag advice for long term care, a quarterly newsletter, online continuing education programs, and more to help facilities manage complex diabetes care in their facilities.

About ARKRAY USA - ARKRAY, the leader in the Long Term Care blood glucose market, has been a pioneer for nearly 50 years in the field of automated analysis from laboratory and point-of-care systems to home use patient self-testing systems. ARKRAY is one of the few diabetes testing companies in the U.S. market today that undertakes in-house each step of the development process to bring products to market. ARKRAY strongly believes in the relentless innovation of medical technology and focused attention to producing the highest quality products. For patients and health care professionals, this means access to cutting-edge, reliable products and customer-focused service.

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