Mendor Discreet

Description:

The Mendor Discreet is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 1-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 Mendor Discreet, 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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★ Recommendation	Older clinical validation; recent protocol
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

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 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2012/95

SKUP. Report from the evaluation SKUP/2012/95: Mendor Discreet (Mendor Oy), a system for blood glucose measurement. Bergen, Norway: SKUP; 2012. 59 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.