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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dip Home-Based Dipstick Analyzer | Experimental | Each participant will test their urine sample using the HBDA. device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dip Home-Based Dipstick Analyzer | Diagnostic Test | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions. | 11 months |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States | ||
| Activmed Practices & Research, Inc. |
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|
| Urine analysis predicate device for professional user | Device | Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user. |
|
| Methuen |
| Massachusetts |
| 01844 |
| United States |
| AccuMed research associates | Garden City | New York | 11530 | United States |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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