Healthy.io Method Comparison & User Performance Study

A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer

The objectives of the Healthy.io Method Comparison and User Performance Study are:

1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
2. To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.

Inclusion Criteria:

1. Subject is male or female, 18-80 years of age

2. Subjects who are healthy or pregnant; or

3. Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):

   • diabetes Type I, Type II, or gestational diabetes (Type III) or,
   • urinary tract infection (UTI)
   • heart disease
   • kidney disease
   • liver disease
   • pregnant women with preeclampsia, gestational diabetes or UTI
   • any pathological findings which might be identified by the urine test (according to the physician discretion)

4. Subject is capable and willing to provide informed consent.

5. Subject has facility with both hands.

6. Subject is capable and willing to adhere to the study procedures

7. Subject is familiar with the use of a smartphone.

Exclusion Criteria:

1. Subject has dementia.
2. Subject has mental disorders.
3. Subject is visually impaired (cannot read the user manual).
4. Subject cannot collect urine in receptacle.
5. Any other reason that might preclude the subject from the study.