Medical Quality

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clinical

Medical Quality

Outstanding Accuracy

All ForaCare’s medical solutions are clinically validated. We strive for continued excellence in clinical competency and our priority is to ensure our solutions meet the emerging requirements for higher accuracy.

EN ISO 13485:2016 Certificate (Q5 092658 0005 Rev. 02)
IVDD EC Certificate (V1 092658 0004 Rev. 03)
MDD EC Certificate (G2 092658 0002 Rev. 02)
MDD EC Certificate (G1 092658 0006 Rev. 01)
MDD EC Certificate (G2M 092658 0007 Rev. 00)
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Clinically proven according to the requirements of the ISO
15197:2013 & EN ISO 15197:2015.

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

​ISO 15197:2013 & EN ISO 15197:2015 Standards

The ISO 15197:2013 & EN ISO 15197:2015 requires that at least 95% of the results from blood glucose meters fall within 15% of laboratory results when glucose levels are equal to or above 100 mg/dL (5.5 rnmol/L) and within 15mg/dL (0.83 mmol/L) when below 100 mg/dL (5.5 mmol/L).
Reference ISO 15197:2013 EN ISO 15197:2015
Organization/PublisherInternational Organization for
Standardization (ISO)		 European Committee
for Standardization
Measurement Tolerance of
< 100 mg/dL (5.55mmol/L)		 + -

15 mg/dL

 + -

15mg/dL
Measurement Tolerance of
≥ 100 mg/dL (5.55mmol/L)		 + -

15%

 + -

15%
Consensus Error Grid99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
accuracy

FORA® 6 Connect Clinical Study

A clinical validation was conducted by Institut fur Diabetes-Technologie Forschungs- und Entwicklungs-Gesellschaft mbH der Universität Ulm with project number IDT-1739(2)-FS in between 30 November 2017 and 19 December 2017. The capillary whole blood samples were taken from 113 different subjects and 600 glucose values were obtained (200 from each of 3 reagent system lots).
FORA@ 6 Connect

Study Results

  • 2
  • 3
  • 1-4
  • 4
FORA 6 PLUS

FORA 6 Plus

Multi-Functional Monitoring System

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FORA 6 CONNECT

FORA 6 Connect

Multi-Functional Monitoring System with Bluetooth

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