This study will test Scanadu Urine Device for clinical performance and usability.
The objectives of this study are to: * Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). * Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. * Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
300
Device to allow lay user to perform urinalysis test at home.
West Coast Research, LLC
Mountain View, California, United States
RECRUITINGWest Coast Research, LLC
San Leandro, California, United States
COMPLETEDUsability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
Time frame: Single visit in one day
Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level.
Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
Time frame: Single visit in one day
Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
Time frame: Single visit in one day
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