- FORA Diamond strips (for the Diamond series) are clinically validated in the Czech Republic and Switzerland and proven to meet the +/- 15% required by ISO 15197:2013.
- FORA Diamond PRIMA was clinically validated in Germany in 2011 and was proven to meet the requirements of the ISO 15197 standards. During the validation testing, 100% of the performance tests fell within the required limits of 20% of the lab results, 97% of the results fell within ± 10 mg/dL (0.56 mmol/L) at glucose concentration < 75 mg/dL (4.2 mmol/L) and 95.5% of the performance testing fell within 15% of the lab results at glucose concentration ≥ 75 mg/dL (4.2 mmol/L).
Please click here to read ForaCare Suisse AG’s Declaration of Equivalence for Clinical Validation Testing.
Please click here to view details of our Clinical Validation Testing and ISO Standards.
Please click here to view graphs depicting the Clinical Validation Results.