TaiDoc TD-4280 GlucoRX Nexus Voice - Medaval

TaiDoc TD-4280 GlucoRX Nexus Voice

Device Name:

GlucoRX Nexus Voice

Device Model:

TD-4280

Manufacturer:

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.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Device Accessibility:

Voiced instructions and results

Availability:

Available Currently

Device Manual:

Click here to download the Device Manual

Description:

The TaiDoc TD-4280 GlucoRX Nexus Voice 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 TaiDoc TD-4280 GlucoRX Nexus Voice, 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:

Khan M, Broadbent K, Morris M, Ewins D, Joseph F. System accuracy evaluation of the GlucoRx nexus voice TD-4280 blood glucose monitoring system. Dis Markers. 2014;2014:602586. Epub: 2014 Oct 13. doi: 10.1155/2014/602586. PMID: 25374434. Retraction in: Dis Markers. 2015;2015:496928.

15197:2013 (aka 15197:2015) - Fail General population

15197:2003 - Fail General population

Relevant Publications:

Khan M, Broadbent K, Morris M, Ewins D, Joseph F. System accuracy evaluation of the GlucoRx nexus voice TD-4280 blood glucose monitoring system. Dis Markers. 2014;2014:602586. Epub: 2014 Oct 13. doi: 10.1155/2014/602586. PMID: 25374434. Retraction in: Dis Markers. 2015;2015:496928.

15197:2013 (aka 15197:2015) - Fail General population

15197:2003 - Fail General population

Nathwani N. Comment on "System Accuracy Evaluation of the GlucoRx Nexus Voice TD-4280 Blood Glucose Monitoring System". Dis Markers. 2015;2015:538785. Epub: 2015 Mar 17. doi: 10.1155/2015/538785. PMID: 25866436. Available from: PMC4381563.

The publication is a letter or correspondence in which the TaiDoc GlucoRX Nexus Voice (TD-4280) is referenced.

Retracted: System Accuracy Evaluation of the GlucoRx Nexus Voice TD-4280 Blood Glucose Monitoring System. Dis Markers. 2015. 496928 p. doi: 10.1155/2015/496928. PMID: 26166933. Available from: PMC4488257.