Bionime Rightest GM700

Device Name:

Rightest

Device Model:

GM700

Manufacturer:

Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, 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 Bionime Rightest GM700 is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Bionime Rightest GM700, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	TÜV Rheinland Nederland	General use	Unpublished internal data
BG	Institute of Health Economics (CA)	General use	No evidence provided
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Huang TY, Chang HW, Tsao MF, Chuang SM, Ni CC, Sue JW, Lin HC, Hsu CT. Evaluation of accuracy of FAD-GDH- and mutant Q-GDH-based blood glucose monitors in multi-patient populations. Clin Chim Acta. 2014 Jun 10;433:28-33. Epub: 2014 Mar 5. doi: 10.1016/j.cca.2014.02.023. PMID: 24613515.

15197:2013 - Pass General population

Wide range of ages and diabetic conditions.

Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.

15197:2013 - Pass General population

15197:2003 - Pass General population