# P190022: 4Kscore Test

- Pathway: PMA
- Applicant: Opko Health, Inc.
- Decided: Dec 7, 2021 after 823 days
- Product code: QRF (Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 31, 2023 · Class II · Z-0516-2024: 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.
- Nov 18, 2022 · Class II · Z-1676-2023: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

Source page: https://510kreport.com/device/P190022
Methodology: https://510kreport.com/methodology