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Arkray Glucocard Vital (GT-1050)
Device Name:
Glucocard Vital
Device Model:
GT-1050
Manufacturer:
Arkray Global Business Inc., 1408 Koji, Konan cho, koka shi, Shiga, JAPAN.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Poland
Device Manual:
Description:
The Arkray Glucocard Vital (GT-1050) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Arkray Glucocard Vital (GT-1050), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG Institute of Health Economics (CA) General use No evidence provided