Clinical Validation Specifics
Clinical ValidationISO 15197

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.

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

Clinically proven to meet the requirement of 15% at glucose levels of 100mg/dL (5.5 mmol/L) or above.

Clinically validated at ForaCare facilities, according to current ISO guidelines and requirements.

Clinically validated by the French Health Products Safety Agency (afssaps)

Clinically validated at the Institute for Diabetes-Technology, University of Ulm, Germany

Clinically validated according to the guidelines and requirements set forth by TNO.

Clinically validated by Professor Nilsson at the Malmö University in Sweden

UBS