Infopia Element

Device Name:Element
Manufacturer:Osang HealthCare (Infopia), 132 Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, REPUBLIC of KOREA.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Infopia Element, to measure blood glucose, has passed in a validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
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

Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013 Jan 1;7(1):144-52. doi: 10.1177/193229681300700117. PMID: 23439170. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3692226/pdf/dst-7-0144.pdf.

15197:2003 - Pass General population