Sinocare Gold-Accu
Device Name:
Gold-Accu
Manufacturer:
Changsha Sinocare Inc., 265 Guyuan Road, Hi-tech Zone, Changsha, Hunan Province 410205, CHINA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Sinocare Gold-Accu is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Sinocare Gold-Accu, 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 | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | MDR Criteria | Self-measurement | Published evidence |
Validation Publications:
Chen H, Yao Q, Dong Y, Tang Z, Li R, Cai B, Wang R, Chen Q. The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria. Prim Care Diabetes. 2019 Jun;13(3):252-258. Epub: 2019 Feb 13. doi: 10.1016/j.pcd.2018.12.010. PMID: 30770203.
15197:2003 - Pass General population
15197:2013 - Pass General population