Arkray Super Glucocard II (GT-1640)
Device Name:
Super Glucocard II
Device Model:
GT-1640
Manufacturer:
Arkray Global Business Inc., 1408 Koji, Konan cho, koka shi, Shiga, JAPAN.
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 Arkray Super Glucocard II (GT-1640) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Arkray Super Glucocard II (GT-1640), 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 |
Not recommended |
This device has failed a clinical validation. |
Validation Publications:
Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.
15197:2013 - Fail General population
15197:2003 - Fail General population
Relevant Publications:
권민정, 이수연 [Kwon MJ, Lee SY.] 혈당측정기 GLUCOCARD X-METER 평가 [Evaluation of GLUCOCARD X-METER glucose monitoring system.] 대한진단검사의학회지 [Korean J Lab Med]. 2008 Feb;28(1):8-15. doi: 10.3343/kjlm.2008.28.1.8. PMID: 18309250. Available from: synapse.koreamed.org. In Korean.
Blind comparison (along with the Roche Accu-Check Active (Probably V1) and the JnJ Lifescan Onetouch Ultra) to the Arkray Glucocard X-Meter.
