Major Bio Smart Chek II

Device Name:

Smart Chek II

Manufacturer:

Major Biosystem Corp., 7F - 186 Jian 1st Rd, Jhonghe District, New Taipei City 235, TAIWAN ROC.

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 Major Bio Smart Chek II 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 Major Bio Smart Chek II to measure blood glucose.

Recommendations:

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