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Bionime Rightest GM700S
Device Name:
Rightest
Device Model:
GM700S
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 GM700S 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 GM700S, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG MDR Criteria Self-measurement Published evidence
Validation Publications:

Tentolouris A, Eleftheriadou I, Grigoropoulou P, Nikoloudi M, Siami E, Tsilimigras DI, Tentolouris N. Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring Systems Journal of Clinical and Diagnostic Research. 2018 Jun;12(6):OC10-OC14. doi: 10.7860/JCDR/2018/34055.11671. Available from: www.jcdr.net.

Ad Hoc protocol General population (Note: Tested in criteria resembling ISO 15197:2013.)

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot. Also passes the more stringent criterion of at least 95% of values within ±10 mg/dL (0.56 mmol/L) or ±10% of the reference measurement procedure’s results.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Pass General population

15197:2013 - Pass General population

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