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Menarini GlucoMen LX Plus

Device Name:GlucoMen LX Plus
Manufacturer:A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.
Measuring functions:Blood glucose, Ketones
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 GlucoMen LX Plus, 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
TÜV Rheinland NederlandGeneral useUnpublished internal data
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

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

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 - Pass 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)

Pfützner A, Demircik F, Ramljak S, Pfützner AH, Berti F, Scuffi C, Valglimigli F. Evaluation of System Accuracy of the GlucoMen LX Plus Blood Glucose Monitoring System With Reference to ISO 15197:2013. J Diabetes Sci Technol. 2016 Mar;10(2):618-9. Epub: 2015 Nov 9. doi: 10.1177/1932296815613803. PMID: 26553022. Available from: PMC4773971. No abstract available.

15197:2013 - Pass General population