OBL: A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.
OEM: Arkray Global Business Inc., 1408 Koji, Konan cho, koka shi, Shiga, JAPAN.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
BG | MDR Criteria | Self-measurement | Published evidence |
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
Mancini A, Esposto G, Manfrini S, Rilli S, Tinti G, Carta G, Petrolati L, Vidali M, Barocci S. A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. J Diabetes Sci Technol. 2018 Sep;12(5):1053-1060. Epub: 2018 May 22. doi: 10.1177/1932296818774077. PMID: 29783898. Available from: PMC6134620.
SIBioC:2015 General population
Note: Results from this paper are not presented due to a number of inaccuracies. One of these refers to the "Glucocard G-sensor" being presented as a device whereas these are test strips for the "Glucocard G" and "Glucocard G+" devices.
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.