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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
429
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.
Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Activmed Practices & Research, Inc.
Methuen, Massachusetts, United States
AccuMed research associates
Garden City, New York, United States
Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
Time frame: 11 months
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.
Time frame: 11 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.