SD Biosensor CHECK GOLD (01GM10)

Device Name:

CHECK GOLD

Device Model:

01GM10

Manufacturer:

SD Biosensor, C 4&5 Floor - Digital Empire Building 16, Deogyeong Dareo 1556beon gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC of KOREA.

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 SD Biosensor CHECK GOLD (01GM10) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the SD Biosensor CHECK GOLD (01GM10) to measure blood glucose.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has not been clinically validated.