Scanadu Urine Device Validation Study Protocol

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