ISO 15197 Standards
The new ISO 15197:2013 requires that at least 95% of the results from blood glucose meters fall within 15% of laboratory results when glucose levels equal to or above 100 mg/dL (5.5 mmol/L) and within 15mg/dL (0.83 mmol/L) when below 100 mg/dL (5.5 mmol/L).
In a recent study of the system accuracy of Diamond MINI, Dr. Tomáš Zima from the Reference Laboratory of the Ministry of Health for Clinical Chemistry in the Czech Republic shows that 98.4% results fall within ±15% accuracy at glucose levels ≥100 mg/dL (5.5 mmol/L). 100% results fall within +/- 15 mg/dL (0.83 mmol/L) accuracy at glucose levels <100 mg/dL (5.5 mmol/L).
COMFORT pro GD40
In 2010, a clinical validation was conducted by the Institute for Diabetes Technology (IDT) at the University of Ulm in Germany, demonstrating that 96% of the FORA Comfort Pro GD40 results fell within 15% of laboratory results. FORA COMFORT Pro GD40 Blood Glucose Monitoring System was proven to exceed the ISO 15197:2003 requirements of ±20%, which has been unbeatable by similar models from other competitors.