GreenCross CeraChek 1Code (G-400)
Device Name:
CeraChek 1Code
Device Model:
G-400
Manufacturer:
GreenCross Medical Science Corp. (Formerly Ceragem Medisys Inc.), 107 Ihyeon-ro 30beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do (Bojeong-dong), 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
Description:
The GreenCross CeraChek 1Code (G-400) 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:
The technology used in the GreenCross CeraChek 1Code (G-400), to measure blood glucose, has failed 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 |
None |
While a clinical validation is claimed, it cannot be checked properly. |
Validation Publications:
Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.
15197:2013 - Fail General population (Note: Modified protocol: One reagent system lot.)
Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.
15197:2013 - Fail General population
15197:2013 - Fail General population
