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Wellion Linus

Device Name:Wellion Linus
Manufacturer:

OBL: MED TRUST Handelsgesellschaft m.b.H. (Wellion), Gewerbepark 10, A-7221 Marz, AUSTRIA.

OEM: AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.

Measuring functions:Blood glucose
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 Wellion Linus, 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.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationRecent clinical validation; older protocol

Validation Publications

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

Chlup R, Doubravova B, Peterson K, Zapletalova J, Bartek J. Wavesense technology glucometer Linus for routine self-monitoring and clinical practice. Acta Diabetol. 2011 Mar;48(1):35-40. Epub: 2010 Aug 9. doi: 10.1007/s00592-010-0213-5. PMID: 20694824.

Ad Hoc protocol General population

Abstract concludes with "Glucometer Linus readings correspond to the ISO and FDA standards. So, Linus appears to be an accurate device for PG-self-monitoring and clinical practice." However, it is unclear which standards are used.

Chlup R, Doubravova B, Bartek J, Zapletalova J, Krystynik O, Prochazka V. Effective assessment of diabetes control using personal glucometers (CONTOURLINK, Bayer, Germany; CALLA, Wellion, Austria; LINUS, Agamatrix, USA). Dis Markers. 2013;35(6):895-905. PMID: 24427777.

Ad Hoc protocol General population

While ISO 15197:2003 and ISO 15197:2013 are mentioned, it is unclear if either was folowed.