

OBL: Sanofi SA, 54 rue La Boétie, 75008 Paris, FRANCE.
OEM: AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | MDR Criteria | Self-measurement | Published evidence |
Jendrike N, Baumstark A, Pleus S, Liebing C, Beer A, Flacke F, Haug C, Freckmann G. Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence. Diabetes Technol Ther. 2018 Apr;20(4):303-13. doi: 10.1089/dia.2017.0391. PMID: 29664706.
15197:2013 - Pass General population
Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.
15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)