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Clinical ValidationISO StandardWhite paper

Diamond Series

The international standard, ISO 15197, requires that at least 95% of the results from blood glucose meters should be within 20% of laboratory results when equal to or above 75 mg/dL and within 15 mg/dL when below 75 mg/dL.

A study of the system accuracy and clinical performance of Diamond Prima was performed in August 2011 at a renowned diabetes institute in Germany. The study showed that Diamond Prima complies with the requirements of ISO 15197 standard by having 100% results falling within the limits.

The study also showed that 95.5% of the results fell within 15% of the laboratory results. Diamond Prima blood glucose monitoring system is clinically proven to meet the emerging needs of providing higher system accuracy to diabetes patient.

FORA’s test strip with its consistent performances and proven utmost qualities has met some of the strictest regulations in the industry and has been validated clinically. The Diamond Series’ test strips can be use on all Diamond range glucose meters.For more details on clinical validation please go to :

http://www.foracare.com/validations.html 
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 Declaration of Equivalence

The excellence in accuracy of Diamond Prima DM10 blood glucose monitoring system is proven with:
• 97% results fell within ± 10 mg/dL (0.56 mmol/L) at glucose concentration < 75 mg/dL (4.2 mmol/L) 
• 95% results fell within 15% at glucose concentration ≥ 75 mg/dL (4.2 mmol/L)

Comfort Pro

The international standard, ISO 15197, requires that at least 95% of the results from blood glucose meters should be within 20% of laboratory results when equal to or above 75 mg/dL and within 15 mg/dL when below 75 mg/dL.

A clinical study done in 2010 was conducted by the institute for Diabetes Technology (IDT) at the University of Ulm in Germany, demonstrating that 96% of the FORA Comfort Pro GD40 results were within 15% of laboratory results. It greatly presents FORA Comfort Pro GD40 Blood Glucose Monitoring System performs well in superior accuracy of 15%, exceeding the ISO standard 20%, which is unbeatable among similar models of competitors.

FORA Comfort Pro GD40 Blood Glucose Monitoring System complies with the requirements of ISO 15197 Standard and its system accuracy is proven with: 
• 97%results falling within ±0.83mmol/L(±15mg/dL) at glucose concentration < 4.2mmol/L(75mg/dL) 
• 99%results falling within ±20% at glucose concentration < 4.2mmol/L(75mg/dL)

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