The Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm is accredited by the Deutsche Akkreditierungsstelle GmbH (DAkkS, ILAC-MRA) as testing laboratory in terms of DIN EN ISO/IEC 17025 for testing of blood-glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015 (In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus).

The following evaluations are offered as accredited analytical performance evaluations of blood-glucose monitoring systems for self-testing in managing diabetes mellitus:

ISO 15197:2013 / EN ISO 15197:2015

Clause 6.2.3               Measurement repeatability

Clause 6.2.4               Intermediate measurement precision

Clause 6.3                  System accuracy

Clause 6.4.3               Packed cell volume evaluation

Clause 6.4.4               Interference testing

Clause 8                     User performance evaluation

A certificate can be provided for these accredited evaluations. If requested by the customer, the certificate will be published on our homepage.



Certificates

2018

2018-09_On Call® Sharp - User performance evaluation

2018-08_On Call® Sharp - Evaluation of system accuracy

2018-07_Actiste, Model No. A0001 - Measurement repeatibility

2018-06_Actiste, Model No. A0001 - User performance evaluation

2018-05_Actiste, Model No. A0001 - Evaluation of system accuracy

2018-04_FORA 6 Connect (GD82) Multi-functional Monitoring System - Evaluation of system accuracy

2018-03_FORA 6 Connect (GD82) Multi-functional Monitoring System - Intermediate measurement precision

2018-02_FORA 6 Connect (GD82) Multi-functional Monitoring System - Measurement repeatibility

2018-01_TRUZIO - Evaluation of system accuracy

 

2017

2017-13_CareSens™ N Premier - Intermediate measurement precision

2017-12_NoCoding1 Plus - Intermediate measurement precision

2017-11_CareSens™ Dual - Intermediate measurement precision

2017-10_CareSens™ Dual - Packed cell volume evaluation

2017-09_CareSens™ N Premier - Evaluation of system accuracy

2017-08_NoCoding1 Plus - Evaluation of system accuracy

2017-07_CareSens™ Dual – Evaluation of system accuracy

2017-06_CareSens™ N Premier - Measurement repeatibility

2017-05_NoCoding1 Plus - Measurement repeatibility

2017-04_CareSens™ Dual - Measurement repeatibility

2017-03_NoCoding1 Plus - User performance evaluation

2017-02_AGM-4000 GlucoDr.auto™ A - Measurement repeatibility

2017-01_AGM-4000 GlucoDr.auto™ A - Packed cell volume evaluation



2016

2016-03_AGM-4000 GlucoDr.auto™ - Evaluation of system accuracy

2016-02_mylife™ Unio™ - Evaluation of system accuracy

2016-01_PixoTest™ - Evaluation of system accuracy