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A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
AccuMed research associates
Garden City, New York, United States
Start Date
June 30, 2019
Primary Completion Date
September 30, 2019
Completion Date
September 30, 2019
Last Updated
July 10, 2020
375
ACTUAL participants
ACR LAB
DEVICE
Lead Sponsor
Healthy.io Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07051005