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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
425
First intervention (assigned to the "All participants" arm).
Second intervention (assigned to the "All participants" arm).
Atlanta Center for Medical Research
Atlanta, Georgia, United States
AccuMed Research Associates
Garden City, New York, United States
Exact and ±1 agreement to compared device
The primary objective of the study is to evaluate the exact agreement and the ±1 color block match of the Dip.io compared to the predicate device, for each analyte concentration (block).
Time frame: Through study completion, an average of 1 month
User performance
All subjects tested should be able to complete device related tasks. The healthcare professionals also recorded their assessment of each subject's use of the new device. The subjects and healthcare inputs were recorded using study questionnaires.
Time frame: Through study completion, an average of 1 month
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