77 Elektronika SensoCard Plus
Device Name:
SensoCard Plus
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
Availability:
Available Currently
Device Manual:
Description:
The 77 Elektronika SensoCard Plus 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 77 Elektronika SensoCard Plus, 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 Assessment | Recommendation | Basis | |
| BG | Medaval | Legacy approval | Older clinical validation; older protocol |
| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
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