Bionime Rightest GM310
Device Name:
Rightest
Device Model:
GM310
Manufacturer:
Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Bionime Rightest GM310 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Bionime Rightest GM310, 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 | Institute of Health Economics (CA) | General use | No evidence provided |
Validation Publications:
Wu MH, Fang MY, Jen LN, Hsiao HC, Müller A, Hsu CT. Clinical evaluation of bionime rightest GM310 biosensors with a simplified electrode fabrication for alternative-site blood glucose tests. Clin Chem. 2008 Oct;54(10):1689-95. Epub: 2008 Aug 1. doi: 10.1373/clinchem.2008.106328. PMID: 18676585. Available from: clinchem.aaccjnls.org.
15197:2003 - Pass General population (Note: Finger and AST validation)