StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Status Completed

Clinical Trial Summary

The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.

Clinical Trial Description

To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method. To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users will be provided with all package insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the lay users other than clarifying the protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05144971
Study type	Observational
Source	Nova Biomedical
Contact
Status	Completed
Phase
Start date	October 28, 2021
Completion date	December 3, 2021

View Details

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