SD Biosensor Codefree (01GM11)
Device Name:
Codefree
Device Model:
01GM11
Manufacturer:
SD Biosensor, C 4&5 Floor - Digital Empire Building 16, Deogyeong Dareo 1556beon gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC of KOREA.
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
Device Specifications:
Description:
The SD Biosensor Codefree (01GM11) is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the SD Biosensor Codefree (01GM11), to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol. |
Validation Publications:
Choukem SP, Sih C, Nebongo D, Tientcheu P, Kengne AP. Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study. Pan Afr Med J. 2019 Mar 14;32:118. doi: 10.11604/pamj20193211815553. PMID: 31223408. Available from: PMC6561013.
Ad Hoc protocol General population