Menarini GlucoMen areo 2K

Device Name:

GlucoMen areo 2K

Manufacturer:

A. Menarini Diagnostics S.r.l., Via Sette Santi 3, 50131 Firenze, ITALY.

Measuring functions:

Blood glucose, β-Ketones

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Device Manual:

Click here to download the Device Manual

Description:

The Menarini GlucoMen areo 2K is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Menarini GlucoMen areo 2K, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	TÜV SÜD (DE)	General use	Unpublished internal data
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Dunseath GJ, Bright D, Luzio SD. Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2019 May;13(3):568-574. Epub: 2019 Jan 9. doi: 10.1177/1932296818821389. PMID: 30623673. Available from: PMC6501526.

15197:2013 - Pass General population (Note: Modified protocol: Single batch of test strips only. Some hematocrit associated bias noted.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Pass General population