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4Kscore Test

by Opko Health, Inc.

PMA P190022

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P190022↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP190022 Date7 Dec 2021ApprovedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0516-2024 FDA Class II initiated 31 Oct 2023

    Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

    • Ongoing Z-1676-2023 FDA Class II initiated 18 Nov 2022

    SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Multi-analyte test system with algorithmic analysis for detection of prostate cancer
PMA Number
FDA Product Code
QRF
Device Class
Class III
Advisory Committee
Immunology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 4Kscore Test is an in vitro serum or plasma test classified as a multi-analyte test system with algorithmic analysis for detection of prostate cancer. It combines results from four immunoassays—total PSA, free PSA, intact PSA, and human kallikrein 2—with patient-specific data, including age, prior biopsy history, and digital rectal exam findings, to generate a single numerical score. This score aids clinicians in assessing the likelihood of aggressive prostate cancer (Gleason score ≥ 7/Gleason Grade Group ≥ 2) in men aged 45 and older with abnormal total PSA levels or digital rectal exam results. The test is designed to support decision-making regarding prostate biopsy referral.

The 4Kscore Test is performed exclusively at BioReference Laboratories, Inc., and is intended for professional use only. It is not intended for repeated use within a six-month period and requires prostate biopsy for definitive cancer diagnosis. The test is supplied as a single-use diagnostic tool, with results derived from algorithmic analysis of immunoassay data. Authorization for the 4Kscore Test was granted under FDA_PMA (PMA Number: P190022) and is categorized under product code QRF in the regulatory database.

Other devices from Opko Health, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of samples can be used for the 4Kscore Test, and how is it performed?

    The 4Kscore Test uses either serum or plasma samples. It combines results from four immunoassays—total PSA, free PSA, intact PSA, and human kallikrein 2—measured using Roche Elecsys platforms. The test also incorporates patient-specific data like age, prior biopsy history, and digital rectal exam findings to generate a single numerical score. However, the test is performed exclusively at BioReference Laboratories, Inc., and is not a point-of-care or in-clinic procedure.

  • Who is the 4Kscore Test intended for, and what age group does it support?

    The 4Kscore Test is designed for men aged 45 and older who have abnormal total PSA levels or abnormal digital rectal exam results. It aids clinicians in assessing the likelihood of aggressive prostate cancer (Gleason score ≥ 7/Gleason Grade Group ≥ 2) to help determine whether a prostate biopsy referral is warranted. It is not intended for routine screening or repeated use within a six-month period.

  • Is the 4Kscore Test reusable, and what are the storage or handling requirements?

    The 4Kscore Test is a single-use diagnostic tool, meaning each test is intended for one patient evaluation only. Since it is performed exclusively at BioReference Laboratories, Inc., specific storage requirements for the sample collection or handling are not applicable to end-users. However, the test requires proper handling of serum or plasma samples, which should be stored and transported according to standard clinical laboratory practices for immunoassay testing.

  • What is the role of the 4Kscore Test in prostate cancer diagnosis, and does it replace a biopsy?

    The 4Kscore Test is an aid in decision-making for prostate biopsy referral, not a definitive diagnostic tool. It helps assess the likelihood of aggressive prostate cancer in men with abnormal PSA or DRE results, but a prostate biopsy remains necessary for a definitive cancer diagnosis. The test is not intended to replace biopsy or be used more frequently than once every six months.

  • How is the 4Kscore Test regulated, and where can it be ordered from?

    The 4Kscore Test is regulated under an FDA Premarket Approval (PMA) with PMA Number P190022. It is categorized under product code QRF in the regulatory database. The test is only available through BioReference Laboratories, Inc., which performs the analysis exclusively, and is intended for professional use only by authorized healthcare providers.