Arkray Glucocard S (GT-7110)

Device Name:

Glucocard S

Device Model:

GT-7110

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

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Arkray Glucocard S (GT-7110) 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 taken from the finger. It is intended for self-measurement and home use.

Assessment:

While the technology used in the Arkray Glucocard S (GT-7110), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	While a clinical validation is claimed, it cannot be checked properly.
BG	TÜV SÜD (DE)	General use	Unpublished internal data