ForaCare Suisse AG Issues Updated Declarations of Equivalence
ST. GALLEN, Switzerland, November 10, 2015 /PRNewswire/ --
ForaCare Suisse AG located in St. Gallen, Switzerland, announced today it is issuing updated Declarations of Equivalence (DOE) for its FORA® Diamond and Comfort lines of blood glucose monitors.
ForaCare strives to provide users with the most advanced technologies while maintaining the highest standards in the industry. As part of ForaCare's efforts to continually improve its products, the company conducts internal and external clinical validations that go above and beyond regulatory and CE requirements.
Widely recognized for their innovation and accuracy, ForaCare's monitoring devices have been used in clinical trials including randomized trials. Most recently, FORA G31b, a blue tooth enabled blood glucose monitoring device was used in a study evaluating telehealth in the treatment and management of diabetes. The study entitled "A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes" was published in a June 2015 issue of the Diabetes Technology & Therapeutics journal.
"We conduct clinical validations using a blood glucose monitoring system that is identical to another system," said Ty-Minh Tan, CEO of ForaCare Suisse AG. "We are happy to report that our FORA® Diamond and Comfort products exceed the minimum ISO and ANSM requirements."
ForaCare declares that devices validated by the following institutes use the same test strip formulas in its COMFORT line: / 4308 / GOD / 0.5uL / 5 seconds and the IC chip on the BGM system and are therefore identical in nature and manufacturing to FORA® COMFORT Plus G30, FORA® COMFORT Voice V30, FORA® COMFORT Advance G31 and FORA® COMFORT Mini G71 for the BGM capability.
FORA® Diamond devices validated by the following institutes use the same test strip formulas / 4365 / GDH-FAD / 0.5uL / 5 seconds and the IC chip on the BGM system and are therefore identical in nature and manufacturing to FORA® Diamond PRIMA (DM10), FORA® Diamond VOICE (DM20), FORA® Diamond MINI (DM30) and the FORA® Diamond GD50 (GD50) for the BGM capability.
Date /
Study Title Place Institute Brief Result
Certificate of
Conformity for
FORA(R) Diamond
PRIMA DM10 Blood
Glucose The BGMS fulfills the
Monitoring Aug. 2015 TÜV SÜD Product Service GmbH requirements of ISO
System Germany (No. 713065869-01) 15197:2013.
Certificate of
Conformity for
FORA(R) Diamond
MINI DM30 Blood
Glucose The BGMS fulfills the
Monitoring Aug. 2015 TÜV SÜD Product Service GmbH requirements of ISO
System Germany (No. 713065869-02) 15197:2013.
This BGMS complies with
the requirements of ISO
15197:2013. System
accuracy results are
Clinical Study 97.0%, 96.5% and 98.0%
Report for within plus or
FORA(R) Diamond minus15mg/dL & plus or
MINI DM30b Blood Institut für minus15%. Results
Glucose Diabetes within Consensus Error
Monitoring April 2015 Technologie Grid zones A and B is
System Germany (IDT-1451-FS) 100%.
Clinical Study
Report for Centre de Biologie
FORA(R) Diamond March 2015 France Sud
Centre Hospitalier
PRIMA DM10 Blood This meter is in
Glucose agreement with all the
Monitoring acceptance criteria of
System Lyon- Sud the ANSM.
This BGMS complies with
the requirements of ISO
15197:2013. System
accuracy results are
Clinical Study 99.0%, 99.5% and 97.0%
Report for within plus or
FORA(R) Diamond minus15mg/dL & plus or
MINI DM30b Blood minus15%. Results
Glucose within Consensus Error
Monitoring Oct. 2014 Grid zones A and B is
System USA AMCR Institute (Fora092614-01) 100%.
Date /
Study Title Place Institute Brief Result
This BGMS complies with the
requirements of ISO
Performance 15197:2013. System accuracy
Evaluation and results are 95.0%, 95.0%
Clinical Study and 96.0% within plus or
Report for FORA(R) minus15mg/dL & plus or
COMFORT Voice V30 minus15%. Results within
Blood Glucose Oct. 2014 AMCR Institute Consensus Error Grid zones
Monitoring System USA (Fora092614-01) A and B is 100%.
This BGMS complies with the
requirements of ISO/DIS
15197:2011. 98.1% results
Evaluation of fell within plus or
system accuracy of ForaCare minus15% at glucose levels
FORA(R) COMFORT of 100 mg/dL or above. 100%
Plus Voice V30 results fell within plus or
blood glucose Jan. 2013 minus15 mg/dL at glucose
monitoring system Taiwan Laboratory levels below 100 mg/dL.
Assessment of the Excellent repeatability and
reliability of reproducibility, and met
FORA(R) COMFORT Dr. Joëlle accuracy requirements. This
Advance G31b blood Goudable Centre meter is in agreement with
glucose monitoring Aug. 2011 Hospitalier all the acceptance criteria
system France Lyon-Sud of the ANSM.
All ForaCare monitoring devices are validated as highly accurate in the industry and provide superior quality directly to consumers. FORA® Blood Glucose Monitors are validated according to ISO 15197 requirements at an internationally renowned diabetes institute in Ulm, Germany.
ForaCare devices comply with new ISO standards and have completed third party validations:
- FORA® Diamond strips (for the Diamond series) are clinically validated in the Czech Republic and Switzerland and is proven to meet the +/- 15% required by the new ISO 15197:2013.
- FORA® Comfort Pro GD40 (with 5-electrode technology) is clinically validated in Switzerland and is proven to meet the +/- 15% required by the new ISO 15197:2013
ForaCare provides FDA cleared and CE marked innovative health monitoring devices that provide simple connection to the FORA system. For more information, please visit http://www.foracare.ch/
About ForaCare Suisse AG: http://www.foracare.ch/
Contact: Elena Birrer, +41-71-220-1001, [email protected]
SOURCE ForaCare Suisse AG
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