
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | Legacy approval | Older clinical validation; older protocol |
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)
Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.
15197:2013 - Fail General population
Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.
15197:2013 - Fail General population (Note: BLS-recorded measurements)
FDA:2016H - Fail General population (Note: BLS-recorded measurements)
15197:2013 - Fail General population (Note: Subject-recorded measurements)
FDA:2016H - Fail General population (Note: Subject-recorded measurements)
15197:2003 - Pass General population
SKUP Evaluation 2009/71
SKUP. Report from the evaluation SKUP/2009/71: GlucoMen LX (A. Menarini Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2009. 57 p. Available from: skup.org.
15197:2003 - Pass General population
Results counted in Sølvik et al. 2015.
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.
Performance with haematocrit variation unstable.