EZ Health Oracle Onyx (GMH-B3, TD-4235C(THI))
Device Name:
Oracle Onyx
Device Model:
GMH-B3, TD-4235C(THI)
Manufacturer:
OBL: Tremblay Harrison Inc. (EZ Health), 1684 Dufferin Street, Toronto, ON M6H 3M1, CANADA.
OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.
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 EZ Health Oracle Onyx (GMH-B3, TD-4235C(THI)) 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:
While the technology used in the EZ Health Oracle Onyx (GMH-B3, TD-4235C(THI)), 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 | Institute of Health Economics (CA) | General use | No evidence provided |