Scanadu Urine Device Validation Study Protocol

Scanadu Urine Device Validation Study Protocol

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

Inclusion Criteria:

• Female and male
• 18 years old or older
• Pregnant or not pregnant
• Must have experience using an Apple iPhone
• Have no visual impairments
• Able to hold Smart Phone horizontally in raised dominant hand
• Must be able to read and understand English
• Must provide Informed Consent

Exclusion Criteria:

• Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app
• Unable to void and collect urine specimen for testing
• Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease