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Menarini Glucocard G+

Device Name:Glucocard G+
Manufacturer:A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.
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 Menarini Glucocard G+, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)

Berti F, Scuffi C, Valgimigli F. Accuracy Evaluation of Two Blood Glucose Monitoring Systems Following ISO 15197:2013. J Diabetes Sci Technol. 2015 Nov;9(6):1354-6. Epub: 2015 Jul 29. doi: 10.1177/1932296815595986. PMID: 26224761. No abstract available.

15197:2013 - Pass General population

Relevant Publications

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.