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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, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaSelf-measurement and professional usePublished evidence

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

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: PMC3692226.

15197:2003 - Pass General population

Jeanny G, Hope P. Surveillance of the System Accuracy of Two Systems for Self-Monitoring of Blood Glucose After Market Approval. J Diabetes Sci Technol. 2016 Jan;10(1):240-1. Epub: 2015 Sep 30. doi: 10.1177/1932296815608871. PMID: 26424240. Available from: PMC4738221. No abstract available.

15197:2013 - Pass General population

15197:2003 - Pass General population

Park HI, Lee SS, Son JW, Kwon HS, Kim SR, Chae H, Kim M, Kim Y, Yoo S. Analytical Performance Evaluation of Infopia Elementâ„¢ Auto-coding Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose. J Clin Lab Anal. 2016 Nov;30(6):449-58. Epub: 2016 Apr 13. doi: 10.1002/jcla.21947. PMID: 27074748.

15197:2013 - Pass General population

Author's Note: Elementâ„¢ BGMS was considered an appropriate SMBG for home use; however, the positive bias at low-to-mid glucose levels requires further improvement.