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  1. Recently-Approved Devices

4Kscore Test – P190022

Image of 4Kscore Test

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: 4Kscore Test
PMA Applicant: OPKO Health, Inc.
Address: 4400 Biscayne Blvd. Miami, FL 33137
Approval Date: December 7, 2021
Approval Letter: Approval Order

What is it?

The 4Kscore Test is an in vitro diagnostic test system designed to evaluate a patient’s likelihood of aggressive prostate cancer by measuring concentrations of four proteins (total PSA, free PSA, intact PSA, and kallikrein 2) in a patient’s blood sample, along with a patient’s age, previous biopsy, and digital rectal exam results.

How does it work?

A patient’s blood sample is sent to a specific laboratory for testing. The blood is analyzed for concentrations of these four proteins in serum or K2EDTA plasma. The 4Ksore Test result is a number calculated by an algorithm based on values using results of these four proteins in combination with a patient’s age, previous biopsy, and digital rectal exam (DRE). A medical professional reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help manage the care of patients with an abnormal age-specific total PSA (tPSA) and/or abnormal DRE.

When is it used?

The 4Kscore Test is used to test patients, ages 45 years and above, with an abnormal age-specific tPSA and/or abnormal DRE finding.

What will it accomplish?

Test results from the 4Kscore Test are used to help doctors determine if a patient has an aggressive prostate cancer.

When should it not be used?

The 4Kscore Test should not be used in patients who:

  • Have a previous diagnosis of prostate cancer
  • Had a digital rectal exam (DRE) performed within 96 hours before blood draw
  • Have used 5-alpha reductase inhibitors within the previous 6 months
  • Had prostate procedures within the previous 6 months

Additional information (including warnings, precautions, and adverse events):

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