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Aktivmed GlucoCheck XL (TD-4277)

Device Name:GlucoCheck XL
Device Model:TD-4277
Manufacturer:

OBL: Aktivmed GmbH, Prinzregentenplatz 1, 86150 Augsburg, GERMANY.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN PRC.

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, 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

Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.

15197:2003 General population (Note: 4 test-strip lots; 2 within requirements)

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 - Pass General population

15197:2013 - Fail General population

Freckman G. Final Report Uright TD-4277. Ulm, Germany: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 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: PMC4667333.

15197:2003 - Pass General population

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

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

Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Högel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. Epub: 2015 May 19. doi: 10.1089/dia.2015.0043. PMID: 26062008.

15197:2013 General population (Note: Results not in Abstract)

Salzsieder E, Berg S. Accuracy Evaluation of a CE-Marked System for Self-Monitoring of Blood Glucose With Three Reagent System Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Jan;10(1):238-9. Epub: 2015 Sep 22. doi: 10.1177/1932296815606471. PMID: 26394775. Available from: PMC4738220. No abstract available.

15197:2013 - Pass General population

TaiDoc GlucoRx Nexus (TD-4277), Menarini GlucoMen Nexus (TD-4277) and Aktivmed GlucoCheck XL (TD-4277) are described as being the same device.