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
2021
2021-01_RIGHTEST™ Max Plus - Evaluation of system accuracy
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
2018-02_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
