Meets the standards of EN ISO 15197:2015
Clinical Validation Specifics
Many products in ForaCare’s blood glucose and blood pressure monitoring systems are clinically validated. Below is a summary of all current and relevant validations. A symbol placed next to the product indicates the validation protocol and the researcher who participated in the study.
FORA strives for continued excellence in clinical competency and our priority is to ensure our blood glucose monitoring systems meet the emerging requirements for higher accuracy in blood glucose measurement including the new ISO criteria of ± 15%.
A printable version of the validation overview of each clinical validation conducted is also available.
Clinically proven according to the requirements of the ISO 15197:2013 & EN ISO 15197:2015.
Clinically validated at ForaCare facilities, according to current ISO guidelines and requirements.
ISO 15197:2013 & EN ISO 15197:2015 Standards
The ISO 15197:2013 & EN ISO 15197:2015 requires that at least 95% of the results from blood glucose meters fall within 15% of laboratory results when glucose levels are 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).
FORA® 6 Connect
In 2017, a clinical validation was conducted by Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH der Universität Ulm with Project number IDT-1739(2)-FS in between 30 November 2017 and 19 December 2017. The capillary whole blood samples taken from 113 different subjects with 600 glucose values were obtained (200 from each of 3 reagent system lots).