PMA · Approved
Recalled · Class II · 20234Kscore Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opko Health, Inc. · QRF Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
Approved on Dec 7, 2021 through premarket approval, which rests on the device’s own clinical evidence after an 823-day review. It has been recalled 2 times.
- Decided
- Dec 7, 2021
- Review
- 823 days
- Class
- Class III
- Product code
- QRF
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P190022 has 3 supplements since 2024: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2024 | 2 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2023 | Class II | Z-0516-2024 | Device Design | 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 | Software Design Change | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results |
No ancestor or descendant has a Class I recall.
How does its category compare?
All QRF devicesQRF Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QRF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRF
Too few QRF 510(k)s in any year since 2007 to give a median.
Recalls per year · QRF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRF
371in 2023
MAUDE reports naming product code QRF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 371 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/P190022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P190022: 4Kscore Test.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P190022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026