ARKRAY, Inc. Receives FDA Clearance For New GLUCOCARD(R) Vital(TM) Blood Glucose Monitoring System

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 06 Nov 2009 - 2:00 PST

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ARKRAY, Inc., the world's 5th largest manufacturer of diabetes self-monitoring systems, announced that it has received 510(k) clearance from the US Food and Drug Administration for its new GLUCOCARD Vital blood glucose monitoring system.

The new meter and strip platform, which ARKRAY will make available for distribution in early December, is expected to be a significant complement to the existing GLUCOCARD line of products, and will be ideal for the home medical equipment (HME), durable medical equipment (DME), mail order and managed care markets.

"We're very excited about the latest addition to our GLUCOCARD brand," said Jonathan Chapman, President of ARKRAY, USA. "The Vital meets all of ARKRAY's rigorous design and performance standards. And we can offer it at a price point that will make it an ideal solution for our customers to use in competitive bidding."

The new GLUCOCARD Vital meter and strip platform is highly accurate, auto-coded, requires only 0.5 microliter of blood, holds 250 dowloadable tests in its memory and has a glucose oxydase (GO) strip chemistry that is not affected by interferences that cause testing errors in other common test strips.

The Vital, along with all GLUCOCARD brands, are backed by ARKRAY's unique YouChoose((TM)) wellness program, a comprehensive education and support system that includes printed tools, videos, recipes and an integrated website designed to help patients manage their diabetes.

About ARKRAY USA

ARKRAY manufactures and distributes high-quality, cost-effective products that are simple, convenient, and easy-to-use, including blood glucose meters, test strips, safety lancets, and urine chemistry. ARKRAY invests heavily in R&D and has a strong commitment to high-quality products. For patients, this means access to cutting-edge, reliable products without sacrificing quality, and exceptional customer service.

Source: ARKRAY, Inc