Nipro 4Sure SmartDuo
Device Name:
4Sure SmartDuo
Manufacturer:
Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.
Measuring functions:
Blood glucose, β-Ketones
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Nipro 4Sure SmartDuo 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 Nipro 4Sure SmartDuo, 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:
System Performance Summary 4SURE SMART DUO Blood Glucose Monitoring System - ISO 15197:2013 / EN ISO 15197:2015 requirements. 2018 Oct. Available from: www.nipro-diagnostics.co.uk.
15197:2013 General population
Internal validation.