PMA · Approved
Recalled · Class II · 2015Pro-Trac II Tacrolimus Elisa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · MLM Enzyme Immunoassay, Tracrolimus
Approved on Apr 27, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 666-day review. It has been recalled 2 times.
- Decided
- Apr 27, 1999
- Review
- 666 days
- Class
- Class II
- Product code
- MLM
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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 MLM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MLM device
- #1 K203833 Tacrolimus Assay Kitscore 5.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|---|
| Mar 16, 2015 | Class II | Z-1464-2015 | Under Investigation by firm | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. |
| Apr 12, 2004 | Not classified | Z-0702-05 | Other | The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MLM devicesMLM Enzyme Immunoassay, Tracrolimus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MLM
Too few MLM 510(k)s in any year since 2007 to give a median.
Recalls per year · MLM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLM
8in 2025
MAUDE reports naming product code MLM, 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 | 2 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 31 |
| 2013 | 1 | — | 1 | 75 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 26 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 1 | — | 0 | 54 |
| 2024 | 0 | — | 0 | 62 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/P970025 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970025: Pro-Trac II Tacrolimus Elisa Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970025
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026