Higher Measuring Accuracy for Diabetes Self-Care
This icon represents ForaCare’s promise and commitment to delivering the highest quality of
diabetes self-care through innovative technologies and solutions. It symbolizes the complete
reassurance in higher measuring accuracy that we offer in blood glucose testing.
ISO 15197:2013, the revised requirements for blood glucose monitoring systems for self-testing
in managing diabetes mellitus, has been published to enforce a stricter accuracy and precision
guidelines for blood glucose meters intended for self-measurement by lay persons.
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%.
| Blood Glucose Monitoring System | Number of Validations |
| FORA Diamond PRIMA (DM10) | Three Validations |
| FORA Diamond VOICE (DM20) | Three Validations |
| FORA Diamond MINI (DM30) | Three Validations |
| FORA iDiamond (DM40) | Three Validations |
| FORA GD20 | Single Validation |
| FORA COMFORT pro GD40 | Single Validation |
| FORA COMFORT lux GD50 | Three Validations |
| FORA G10 | Single Validation |
| FORA G11 | Single Validation |
| FORA G12 | Single Validation |
| FORA COMFORT basic G20 | Two Validations |
| FORA COMFORT plus G30a | Four Validations |
| FORA COMFORT advance G31a | Three Validations |
| FORA COMFORT advance G31b | Three Validations |
| FORA COMFORT basic mini G70 | Single Validation |
| FORA COMFORT plus mini G71a | Three Validations |
| FORA COMFORT basic voice V10 | Two Validations |
| FORA V11 | Single Validation |
| FORA V12 | Single Validation |
| FORA V30 | Three Validations |
| FORA S10a | Single Validation |
| Number of Validations | Blood Glucose / Blood Pressure 2-in-1 Monitoring System |
ESH 2002 | ESH 2010 | Dabl |
| 1 | FORA D30 | PASS | Recommended | |
| 1 | FORA D40b | PASS | Recommended | |
| 1 | FORA P30 Plus | PASS | Recommended | |
| 1 | FORA Diamond CUFF BP | PASS | Recommended |
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Clinically proven to meet the requirement of 15% at glucose levels of 100mg/dL (5.5 mmol/L) or above. |
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Clinically validated at ForaCare facilities, according to current ISO guidelines and requirements. |
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Clinically validated by the French Health Products Safety Agency (afssaps) |
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Clinically validated at the Institute for Diabetes-Technology, University of Ulm, Germany |
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Clinically validated according to the guidelines and requirements set forth by TNO. |
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Clinically validated by Professor Nilsson at the Malmö University in Sweden |
