FDA Gives the Nod to New BGM System From ARKRAY
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.
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