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

Study Overview
=================
Brief Summary
-----------------
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) 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 HBDA 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 HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

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

Conditions
-----------------
Urine Detectable Acute and Chronic Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Dip Home-Based Dipstick Analyzer
* Device: Urine analysis predicate device for professional user


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18-80 years of age Subjects who are healthy or pregnant; or 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 Subject is capable and willing to provide informed consent. Subject has facility with both hands. Subject is capable and willing to adhere to the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dip Home-Based Dipstick Analyzer<br>Each participant will test their urine sample using the HBDA. device | Diagnostic Test: Dip Home-Based Dipstick Analyzer<br>* The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.<br>Device: Urine analysis predicate device for professional user<br>* Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user. |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions. |  | 11 months |