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Roche Accu-Chek Active (V1)

Device Name:Accu-Chek Active
Manufacturer:Sole: Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, 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 Roche Accu-Chek Active (V1), 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-measurementPublished evidence

Validation Publications

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

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 - Pass General population

Baumstark A, Schmid C, Pleus S, Rittmeyer D, Haug C, Freckmann G. Accuracy assessment of an advanced blood glucose monitoring system for self-testing with three reagent system lots following ISO 15197:2013. J Diabetes Sci Technol. 2014 Nov;8(6):1241-2. Epub: 2014 Aug 7. doi: 10.1177/1932296814546529. PMID: 25107707. Available from: PMC4455471.

15197:2013 - Pass General population

Хоровская ЛА, Лобачевская ТВ, Черничук ОВ. [Horovskaia LA, Lobachevskaia TV, Chernichuk OV.] Аналитическое Качество и Оценка Сопоставимости Четырех Глюкометров Разных Производителей [The analytical quality and comparability value of four glucometers from different manufacturers.] клин лаб диагностика [Klin Lab Diagn.]. 2015 Jan;60(1):60-3. PMID: 25874308. Available from: cyberleninka.ru. In Russian.

15197:2013 - Pass General population

It is unclear from the publication which Accu-Chek Active device was used in the study. The date suggests that the version Medaval has indicated as "V2" was used. However, the study results cannot be applied unless this is clarified.

Kamecke U, Baumstark A, Jendrike N, Haug C, Freckmann G. Accuracy Assessment of an Improved Version of an Established Blood Glucose Monitoring System for Self-Testing Following ISO 15197:2013. J Diabetes Sci Technol. 2017 Jul;11(4):851-3. Epub: 2017 Jan 25. doi: 10.1177/1932296816688304. PMID: 28627219. Available from: PMC5588828.

15197:2013 - Pass General population

Freckmann G, Baumstark A, Jendrike N, Rittmeyer D, Pleus S, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements. Diabetes Technol Ther. 2017 Apr;19(4):246-54. Epub: 2017 Feb 22. doi: 10.1089/dia.2016.0341. PMID: 28225633.

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

It is unclear from the publication which Accu-Chek Active device was used in the study. The date suggests that the version Medaval has indicated as "V2" was used. However, no study results can be applied unless this is clarified.

Relevant Publications

권민정, 이수연 [Kwon MJ, Lee SY.] 혈당측정기 GLUCOCARD X-METER 평가 [Evaluation of GLUCOCARD X-METER glucose monitoring system.] 대한진단검사의학회지 [Korean J Lab Med]. 2008 Feb;28(1):8-15. doi: 10.3343/kjlm.2008.28.1.8. PMID: 18309250. Available from: synapse.koreamed.org. In Korean.

Blind comparison (along with the Arkray Super Glucocard II and the JnJ Lifescan Onetouch Ultra) to the Arkray Glucocard X-Meter. It is unclear from the publication which Accu-Chek Active device was used in the study. The date suggests that the version Medaval has indicated as "V1" was used.