
#CONTOUR NEXT ONE ACCURACY ISO#
§ In a clinical study, conducted in accordance with the requirements of ISO 15197:2013, the CONTOUR ® NEXT ONE not only met and exceeded the minimum requirements of the standard but an ad hoc analysis determined where 95% of results fell during the study, which was within ☐.47 mmol/L or ☘.4% of the laboratory reference value for glucose concentrations < 5.55 mmol/L or ≥5.55 mmol/L, respectively, when tested via subject obtained capillary fingertip results (patients). laboratory method for blood glucose concentrations < 5.55 mmol/L.

laboratory method, specifically: 97.4% of results within ☑0% for blood glucose concentrations ≥5.55 mmol/L, and 100% of results within ☐.56 mmol/L accuracy vs. ‡ CONTOUR ® NEXT ONE meter meets ☑0% accuracy vs. † Current regulation based on Health Canada recognized ISO 15197:2013 standard requires results within ☑5% range, specifically: ≥95% of results must fall within ☐.83 mmol/L for blood glucose concentrations < 5.55 mmol/L and within ☑5% for blood glucose concentrations ≥5.55 mmol/L. Analysis performed by Ascensia, based on volume data provided by IQVia. * Volume of blood glucose test strips from specific brands as of July 2020 MAT in Retail market not demonstrated to meet current ISO standards.
