ApexBio GlucoSure Voice
Device Name:
GlucoSure Voice
Manufacturer:
Apex Biotechnology Corp., 7 Li-Hsin Road V, Hsinchu Science Park, Hsinchu 30078, TAIWAN ROC.
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
Device Accessibility:
Voiced instructions and results
Availability:
Discontinued but still available
Device Manual:
Description:
The ApexBio GlucoSure Voice 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the ApexBio GlucoSure Voice, 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |