Table 3.

Overall determination of the accuracy of the GlucoRx Nexus TD-4280 blood glucose monitoring device relative to the accuracy limits defined in both the ISO 15197:2003 and ISO 15197:2013 guidelines.

	DIN EN ISO 15197:2003	DIN EN ISO 15197:2013
Accuracy limits set by guideline	±15 mg/dL (0.83 mmol/L) and ±20%	±15 mg/dL (0.83 mmol/L) and ±15%
Percentage of results required to be within this limit for meter to be deemed accurate	≥95%	≥95%
Number of results obtained within this limit	97/105	91/105
Percentage of results obtained within this limit (%)	92.4	86.7
Are ≥95% of the readings within the accuracy limits set in guidelines? (Yes/no)	No	No