Trials / Completed
CompletedNCT04466501
ACR | LAB Urine Analysis Test System Evaluation of Performance
A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 375 (actual)
- Sponsor
- Healthy.io Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm. The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACR LAB | The ACR \| LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. |
Timeline
- Start date
- 2019-06-30
- Primary completion
- 2019-09-30
- Completion
- 2019-09-30
- First posted
- 2020-07-10
- Last updated
- 2020-07-10
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04466501. Inclusion in this directory is not an endorsement.