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HMM SmartLAB Mini

Device Name:SmartLAB Mini
Device Model:mg/dL D10425MG, mmol/L D10425MM
Manufacturer:HMM Holding AG, 89 Friedrichstra├če, D 69221 Dossenheim, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The HMM SmartLAB Mini is a non-clinically-validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:

The technology used in the HMM SmartLAB Mini, to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.

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