ForaCare Suisse AG Issues Updated Declarations of Equivalence

Nov 10, 2015, 03:00 ET from ForaCare Suisse AG

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, Elena.birrer@foracare.com

SOURCE ForaCare Suisse AG