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Wellion Calla Light
Device Name:
Calla Light
Manufacturer:
MED TRUST Handelsgesellschaft m.b.H. (Wellion), Gewerbepark 10, A-7221 Marz, AUSTRIA.
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
Description:
The Wellion Calla Light is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Wellion Calla Light, 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 AssessmentRecommendationBasis
BG Medaval Legacy approval Older clinical validation; older protocol
Validation Publications:

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Fail General population

15197:2013 - Fail General population

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.

SKUP. Report from the evaluation SKUP/2013/87: Wellion Calla Light (MED TRUST Handelsgesellschaft), a system for blood glucose measurement. Uppsala, Sweden: SKUP; 2013. 59 p. Available from: skup.org.

15197:2003 General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)

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