Wellion Calla Dialog
Device Name:
Calla Dialog
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 Dialog is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. 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 Dialog, to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | Not recommended | This device has failed a clinical validation. |
Validation Publications:
Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.
15197:2003 - Fail Using insufficient blood samples (n=31)