The technology used in the GE GE100, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|MDR Criteria||Self-measurement||Published evidence|
Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.
15197:2003 - Pass General population
15197:2013 - Pass General population