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ACR | LAB Urine Analysis Test System Evaluation of Performance

NCT04466501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2020-07-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Healthy.io Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466501 on ClinicalTrials.gov