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Clinical Validation
Clinical ValidationISO StandardWhite paper

Many of our blood glucose monitoring systems and blood pressure monitoring systems are clinically validated. A symbol is placed next to the product to indicate the validation protocol and the researcher who participated in the study. Below you will find an overview of all our current and relevant validations for our blood glucose and blood pressure monitoring systems.

As Fora Care continues to strive for excellence in clinical competency, our blood glucose monitoring systems continue meet the emerging needs of higher accuracy in blood glucose measurement and meet the new ISO criteria of ± 15%.

To download a printable version of our clinical validation study list, click FORA clinical validation list. This document will provide you information about the test results for each of the clinical validation conducted.

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

 

Clinically proven to meet the requirement of ±15% at glucose levels of 100mg/dL or above.

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

Clinically validated by the Agence nationale de sécurité du médicament et des produits de santé (ANSM)

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