Distributer: GlucoRx Ltd., 4 Wintonlea, Monument Way West, Woking, Surrey GU21 5EN, UNITED KINGDOM.
OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Self-measurement and professional use | Published evidence |
Salzsieder E, Berg S. Accuracy Evaluation of a CE-Marked System for Self-Monitoring of Blood Glucose With Three Reagent System Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Jan;10(1):238-9. Epub: 2015 Sep 22. doi: 10.1177/1932296815606471. PMID: 26394775. Available from: PMC4738220. No abstract available.
15197:2013 - Pass General population
TaiDoc GlucoRx Nexus (TD-4277), Menarini GlucoMen Nexus (TD-4277) and Aktivmed GlucoCheck XL (TD-4277) are described as being the same device.
Vanterpool GE. Accuracy of a Blood Glucose Monitoring System. J Diabetes Sci Technol. 2016 Jul;10(4):995-996. Epub: 2016 Feb 17. doi: 10.1177/1932296816630330. PMID: 26892507. Available from: PMC4928233. No abstract available.
15197:2013 - Pass General population
See: J Diabetes Sci Technol. 2018 Jul;12(4):894-895 and J Diabetes Sci Technol. 2018 Jul;12(4):896-897.
Gonzalez-Durio J. In Response to a Previous Letter to the Editor Titled, "Accuracy of a Blood Glucose Monitoring System". J Diabetes Sci Technol. 2018 Jul;12(4):894-895. Epub: 2018 Mar 13. doi: 10.1177/1932296818763466. PMID: 29529874. Available from: PMC6134293.
See: J Diabetes Sci Technol. 2016 Jul;10(4):995-996 and J Diabetes Sci Technol. 2018 Jul;12(4):896-897.
Vanterpool GE. In Response to Gonzalez-Durio: "In Response to a Previous Letter to the Editor Titled, 'Accuracy of a Blood Glucose Monitoring System'". J Diabetes Sci Technol. 2018 Jul;12(4):896-897. Epub: 2018 Apr 5. doi: 10.1177/1932296818767939. PMID: 29619892. Available from: PMC6134318.
See: J Diabetes Sci Technol. 2016 Jul;10(4):995-996 and J Diabetes Sci Technol. 2018 Jul;12(4):894-895.