Aktivmed GlucoCheck XL (TD-4277)

Device Name:GlucoCheck XL
Device Model:TD-4277
Manufacturer:Aktivmed GmbH, Prinzregentenplatz 1, 86150 Augsburg, GERMANY.
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 Aktivmed GlucoCheck XL (TD-4277), to measure blood glucose, has passed in four validation studies, in general 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 - Pass General population

15197:2013 - Fail General population

Freckman G. Final Report Uright TD-4277. 24 p.

15197:2003 - Pass General population

Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161. PMID: 25872967. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4667333/pdf/10.1177_1932296815580161.pdf.

15197:2003 - Pass General population

15197:2013 - Fail General population (Note: GOx Comparison (Manufacturer))

15197:2013 - Fail General population (Note: HK Comparison (Alternative))