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FDA Gives the Nod to New BGM System From ARKRAY


Nov 17, 2009

Arkray developed the world's first hand-held blood glucose meter in the late 1960s and the world's first HbA1c analyzer in 1982.

The Food and Drug Administration has given ARKRAY, Inc., a 510(k)* clearance to begin marketing its new GLUCOCARD® VitalTM blood glucose monitoring system in the United States.

ARKRAY, one of the world's largest manufacturers of diabetes self-monitoring systems, will begin distributing the meter and strip platform in early December. Channels will include the existing market for the GLUCOCARD line of products, as well as the mail order, managed care, home medical equipment, and durable medical equipment markets.

Features of the new BGM system include:

  • Glucose oxidase test strips that are said to reduce the chance of false readings
  • Auto coding
  • 0.5 microliter test sample size
  • 250 test downloadable memory
  • 14 or 30 day averages
  • 7 second test time
  • Time and date stamp

ARKRAY says that users of the new Vital system may participate in the company's YouChoose((TM)) wellness program, an education and support system that includes printed tools, videos, recipes, and a dedicated website designed to help patients manage their diabetes.

* 510(k) is the section of the Federal Food, Drug and Cosmetic Act from which the FDA derived its process for approving new medical devices. Gaining 510(k) approval means that the FDA has determined that a new device is "substantially equivalent" in safety and effectiveness to similar devices that are already on the market. The section does not require that such devices be made from the same materials as similar devices or based on the same technology-a fortunate bit of wiggle room that leaves the door open to innovation.

* * *

www.glucocardusa.com


Categories: Blood Glucose, Diabetes, Diabetes, Food, Meters, Monitoring, Products, Type 1 Issues, Type 2 Issues



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Comments

Posted by Jerry1423 on 18 November 2009

What am I missing here ? ....

This looks like just another addition to the zillions of BG meters already out there, and the all do the same thing in the same way.
I would welcome it if it was something that benefitted the diabetic by the better way of testing, but it is not.

Posted by Anonymous on 11 February 2010

Maybe you are missing the price of the strips for an auto coded meter

Posted by Anonymous on 9 April 2010

Is there a meter out there that lets you flag your injection time?


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