Urinary Tract Infections Clinical Trial
Official title:
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a
kit and a smartphone application. The device will be provided to the subject in a simulated
home-use environment. All subjects will be asked to complete the urine test by following the
application guidance,including providing a urine sample and scanning the urine strip after
placing it on the Color-Board. The user will also complete a questionnaire to collect
information regarding the use of the Velieve U.S. device. Following the usability test
performed by the lay user, the subject's urine sample will be tested by the professional user
using the comparator device.
The use of the Velieve U.S. device will be evaluated for identified risks. Additionally,
measurable usability criteria for specific, critical steps will be evaluated.
n/a
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