PMA · Approved
Recalled · Class II · 2024Immulite Systems Psa & Third Generation Psa Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Approved on Sep 15, 1995 through premarket approval, which rests on the device’s own clinical evidence after a 766-day review. It has been recalled 7 times.
- Decided
- Sep 15, 1995
- Review
- 766 days
- Class
- Class III
- Product code
- MTF
- Recalls
- 7
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P930027 has 34 supplements since 1996: 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 |
|---|---|
| 1996 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 2 |
| 2014 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 4 |
| 2026 | 4 |
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?
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 |
|---|---|---|---|---|
| Sep 30, 2024 | Class II | Z-0464-2025 | Under Investigation by firm | The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU). |
| Dec 21, 2016 | Class II | Z-1119-2017 | Nonconforming Material/Component | Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16%… |
| Dec 21, 2016 | Class II | Z-1120-2017 | Nonconforming Material/Component | Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average… |
| Nov 18, 2016 | Class II | Z-0884-2017 | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. |
| Nov 18, 2016 | Class II | Z-0885-2017 | Under Investigation by firm | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. |
| Jun 26, 2013 | Class II | Z-2047-2013 | Software design | Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an… |
| May 21, 2008 | Not classified | Z-2090-2008 | Other | The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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/P930027 · printed Nov 6, 2026
Cite this page
510(k) Report. “P930027: Immulite Systems Psa & Third Generation Psa Reagents.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P930027
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026