ForaCare’s Commitment to Quality and the Highest Measurement Standards

ForaCare Suisse AG is committed to meeting the highest measurement standards. Medical professionals trust the performance of ForaCare products and patients have peace of mind knowing they are in good hands. Life can be complicated but ForaCare’s products keep it simple, standardized and safe for you and for anyone in your life who relies on us for the testing and management of a diabetes-related health condition.

Clinical Validation

All FORA Diamond blood-glucose monitors are validated as highly accurate in the industry, meeting the international standards of ISO 15197:2013 requirements. ISO 15197 standards stipulate that at least 95% of the results from blood-glucose meters should be within 15% of the laboratory results when equal to or above 100 mg/dL (5.5 mmol/L) and within 15 mg/dL (0.83 mmol//L) when below 100 mg/dL (5.5 mmol/L).

ForaCare devices have undergone the following third-party validations:

- 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).

Learn More!

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.