77 Elektronika GlucoTalk

Device Name:

GlucoTalk

Manufacturer:

77 Elektronika Kft, Fehérvári út 98, H-1116 Budapest, HUNGARY.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Device Accessibility:

Voiced instructions and results

Availability:

Available Currently

Description:

The 77 Elektronika GlucoTalk is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the 77 Elektronika GlucoTalk, 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. However, it was also assessed in another study, but the results have not been published and cannot be verified.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	While a clinical validation is claimed, it cannot be checked properly.
BG	TÜV Rheinland Nederland	General use	Unpublished internal data

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)