PMA · Approved
ApprovedTandem-R Psa Immunoradiometric Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Approved on Feb 25, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 231-day review. 3 later devices descend from it.
- Decided
- Feb 25, 1986
- Review
- 231 days
- Class
- Class III
- Product code
- MTF
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceP850048 Tandem-R Psa Immunoradiometric AssayBeckman Coulter, Inc. · 1986
- Descendant · cites it directly · 0 of its ownK984289 Vitros Immunodiagnostic Products Psa Calibrators, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK974816 Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer…Beckman Instruments, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK965085 Enzymun-Test PsaBoehringer Mannheim Corp. · 1997
Most influential descendants
Showing 3 of 3 · See all- K984289Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa…Ortho-Clinical Diagnostics, Inc. · 1999 · cites it directly0descendants
- K974816Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229Beckman Instruments, Inc. · 1998 · cites it directly0descendants
- K965085Enzymun-Test PsaBoehringer Mannheim Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P850048 | Tandem-R Psa Immunoradiometric Assay | Beckman Coulter, Inc. | 1986 | — |
| +1 | K984289 | Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| +1 | K974816 | Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225… | Beckman Instruments, Inc. | 1998 | — |
| +1 | K965085 | Enzymun-Test Psa | Boehringer Mannheim Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
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 MTF? 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984289 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MTF devicesMTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MTF
Too few MTF 510(k)s in any year since 2007 to give a median.
Recalls per year · MTF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTF
65in 2025
MAUDE reports naming product code MTF, 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 | 5 | — | 0 | 1 |
| 2008 | 9 | — | 1 | 4 |
| 2009 | 7 | — | 0 | 3 |
| 2010 | 10 | — | 0 | 5 |
| 2011 | 26 | — | 0 | 10 |
| 2012 | 19 | — | 1 | 17 |
| 2013 | 16 | — | 0 | 89 |
| 2014 | 14 | — | 0 | 12 |
| 2015 | 8 | — | 1 | 17 |
| 2016 | 6 | — | 2 | 16 |
| 2017 | 12 | — | 0 | 39 |
| 2018 | 10 | — | 0 | 30 |
| 2019 | 8 | — | 0 | 21 |
| 2020 | 14 | — | 0 | 14 |
| 2021 | 6 | — | 0 | 46 |
| 2022 | 5 | — | 0 | 45 |
| 2023 | 10 | — | 0 | 29 |
| 2024 | 4 | — | 1 | 31 |
| 2025 | 8 | — | 0 | 65 |
| 2026 | 9 | — | 0 | — |
https://510kreport.com/device/P850048 · printed Nov 6, 2026
Cite this page
510(k) Report. “P850048: Tandem-R Psa Immunoradiometric Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850048
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026