OKmeter Direct (OK-1N)
Device Name:
Direct
Device Model:
OK-1N
Manufacturer:
OK Biotech Co. Ltd., 91 Sec. 2, Gongdao 5th Road, Hsinchu City 30070, 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
Availability:
Available Currently
Device Specifications:
Description:
The OKmeter Direct (OK-1N) 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 OKmeter Direct (OK-1N), 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |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 |