AgaMatrix iBGStar

Device Name:iBGStar
Manufacturer:AgaMatrix, Pharma Supply, Inc10 Manor Parkway, 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
Assessment: The technology used in the AgaMatrix iBGStar, to measure blood glucose, has passed in two validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

15197:2003 - Fail General population

15197:2013 - Fail 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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

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