AgaMatrix Sanofi iBGStar
Device Name:
iBGStar
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
Device Manual:
Click here to download the Device Manual
Description:
The AgaMatrix Sanofi iBGStar 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 iBGStar, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in four clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG FDA (US) 510(k) 510(k) K103544
BG TÜV Rheinland Nederland General use Unpublished internal data
BG MDR Criteria Self-measurement Published evidence
Device Family:
AgaMatrix Sanofi iBGStarF, AgaMatrix Wavesense JazzF, AgaMatrix LibertyF
Legend: F FDA 510(k)
Validation Publications:

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Fail General population

15197:2013 - Fail General population

Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.

15197:2003 - Pass General population

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Pass Using insufficient blood samples (n=31)

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Pass General population

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Pass General population

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

AgaMatrix Wavesense Jazz

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Fail General population

15197:2013 - Fail General population

Grant DA, Dunseath GJ, Bain SC, Luzio S. Postmarket Approval Surveillance of a Low Acquisition Cost Blood Glucose Monitoring System: Assessment of the Accuracy Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Sep;10(5):1195-6. Epub: 2016 May 12. doi: 10.1177/1932296816648991. PMID: 27179012. Available from: PMC5032959.

15197:2013 - Pass General population

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