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Bionime Rightest GM700

Device Name:Rightest
Device Model:GM700
Manufacturer:Sole: Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN PRC.
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
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 clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaSelf-measurementPublished 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