PMA · Approved
Recalled · Class II · 2018Aia-Pack Psa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Approved on Jul 7, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 602-day review. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 7, 1993
- Review
- 602 days
- Class
- Class III
- Product code
- MTF
- Recalls
- 1
2 later devices descend from it, 1 citing it directly.
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) | P910065 | Aia-Pack Psa | Tosoh Bioscience, Inc. | 1993 | — |
| +1 | K124056 | Frend Psa Plus (Reagent Cartridge) | Nanoentek, Inc. | 2013 | — |
| +2 | K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124056 | Frend Psa Plus (Reagent Cartridge) | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2018 | Class II | Z-2067-2018 | Device Design | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K124056 (Nanoentek, Inc., 2013) has gone furthest, with 1 descendant 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/P910065 · printed Nov 6, 2026
Cite this page
510(k) Report. “P910065: Aia-Pack Psa.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910065
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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