PMA · Approved
Recalled · Class II · 2016Advia Centaur & Advia Centaur CP Psa Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Approved on Dec 22, 1995 through premarket approval, which rests on the device’s own clinical evidence after a 178-day review. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 22, 1995
- Review
- 178 days
- Class
- Class III
- Product code
- MTG
- Recalls
- 1
1 later device descends from it, 1 citing it directly.
- This deviceP950021 Advia Centaur & Advia Centaur CP Psa ImmunoassaySiemens Healthcare Diagnostics · 1995
- Descendant · cites it directly · 0 of its ownK251630 Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251630Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P950021 | Advia Centaur & Advia Centaur CP Psa Immunoassay | Siemens Healthcare Diagnostics | 1995 | — |
| +1 | K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 MTG? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251630 | Atellica IM Total PSA II (tPSAII) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2016 | Class II | Z-2742-2016 | Under Investigation by firm | Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K251630 (Siemens Healthcare Diagnostics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MTG devicesMTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MTG
Too few MTG 510(k)s in any year since 2007 to give a median.
Recalls per year · MTG
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTG
20in 2025
MAUDE reports naming product code MTG, 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 | 7 | — | 0 | 0 |
| 2008 | 7 | — | 1 | 0 |
| 2009 | 3 | — | 0 | 0 |
| 2010 | 9 | — | 0 | 0 |
| 2011 | 25 | — | 1 | 3 |
| 2012 | 17 | — | 0 | 4 |
| 2013 | 12 | — | 0 | 3 |
| 2014 | 13 | — | 0 | 1 |
| 2015 | 7 | — | 0 | 9 |
| 2016 | 3 | — | 0 | 5 |
| 2017 | 9 | — | 0 | 8 |
| 2018 | 7 | — | 0 | 12 |
| 2019 | 9 | — | 0 | 13 |
| 2020 | 13 | — | 0 | 6 |
| 2021 | 7 | — | 0 | 9 |
| 2022 | 4 | — | 0 | 4 |
| 2023 | 9 | — | 0 | 5 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 6 | — | 0 | 20 |
| 2026 | 6 | — | 0 | — |
https://510kreport.com/device/P950021 · printed Nov 5, 2026
Cite this page
510(k) Report. “P950021: Advia Centaur & Advia Centaur CP Psa Immunoassay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P950021
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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