FORA 6 Connect Proves its Outstanding Quality and Accuracy Through Multiple Clinical Studies
ForaCare’s FORA 6 Connect has been continuously proven to be a reliable device to measure not only blood glucose but multiple parameters including Hematocrit, Hemoglobin, β-ketone, Total Cholesterol and Uric Acid.
Blood Glucose Validations
In January 2019, FORA 6 has obtained its full ISO 15197:2013 / EN ISO 15197:2015 certificate from TÜV SÜD, the world’s leading notified body. The FORA 6 Connect fulfilled system accuracy requirements with ≥99% of results within ±15 mg/dl or ±15% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD ≤2.2 mg/dl and CV ≤2.3%. Analysis of measurement repeatability showed SD ≤2.1 mg/dl and CV ≤2.4%.
Consensus Error Grid for FORA 6 Connect with three reagent system lots
Since June 2015, FORA 6 Connect Blood Glucose Monitoring System has gone through multiple clinical validations, each conducted in different countries and clinical centers to assure its consistency and quality in measurement accuracy.
For blood glucose monitoring, FORA 6 Connect has passed five clinical validations:
To know more about the clinical validations' results, click here.
Other Measurement Parameters Validations
In addition, in April 2017, various clinical studies conducted by Primary Care Settings, Taiwan, has also tested FORA 6’s Multiple-parameters including β-ketone, Total Cholesterol and Uric Acid, and the results showed that FORA 6 Connect measurements regarding β-ketone, Total Cholesterol and Uric acid are all within ±15% when compared to the test results taken from laboratory reference. To view the white papers, click here.
For more information about FORA 6 Connect or its clinical validations, please contact us.