AgaMatrix Sanofi MyStar DoseCoach

Device Name:

MyStar DoseCoach

Manufacturer:

OBL: Sanofi SA, 54 rue La Boétie, 75008 Paris, FRANCE.

OEM: AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The AgaMatrix Sanofi MyStar DoseCoach is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the AgaMatrix Sanofi MyStar DoseCoach, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

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.)