PMA · Approved
ApprovedAxsym Total Psa & Architect Total Psa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Approved on Sep 25, 1991 through premarket approval, which rests on the device’s own clinical evidence after a 208-day review. 2 later devices descend from it.
- Decided
- Sep 25, 1991
- Review
- 208 days
- Class
- Class III
- Product code
- MTF
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceP910007 Axsym Total Psa & Architect Total PsaAbbott Laboratories · 1991
- Descendant · cites it directly · 0 of its ownK994419 Fastpack Psa Immunoassay, Fastpack SystemQualisys Diagnostics, Inc. · 2000 · Recalled
- Descendant · cites it directly · 0 of its ownK990234 Qualisys Psa ImmunoassayQualisys Diagnostics, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P910007 | Axsym Total Psa & Architect Total Psa | Abbott Laboratories | 1991 | — |
| +1 | K994419 | Fastpack Psa Immunoassay, Fastpack System | Qualisys Diagnostics, Inc. | 2000 | 2 |
| +1 | K990234 | Qualisys Psa Immunoassay | Qualisys Diagnostics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (2)
2 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, K994419 (Qualisys Diagnostics, Inc., 2000) 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/P910007 · printed Nov 6, 2026
Cite this page
510(k) Report. “P910007: Axsym Total Psa & Architect Total Psa.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910007
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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