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

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.

Inclusion Criteria:

• Men and women 18-80 years of age;

• Subjects who are healthy or pregnant; or

• Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  • Diabetes Type I/Type II,
  • Hypertension,
  • Any kidney disease,
  • Other relevant conditions.

• Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);

• Subject is capable and willing to provide informed consent;

• Subject has facility with both hands

• Subject is capable and willing to adhere to the study procedures.