Fora Diamond (GD50)
Device Name:
Fora Diamond (aka Comfort Lux)
Device Model:
GD50
Manufacturer:
ForaCare Suisse AG, Neugasse 55, CH-9000 St. Gallen, SWITZERLAND.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates and Switzerland
Device Manual:
Description:
The Fora Diamond (GD50) 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 normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
While the technology used in the Fora Diamond (GD50), to measure blood glucose, has been assessed, the results of the study 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| BG | TÜV SÜD (DE) | General use | Unpublished internal data |