PMA · Approved
Recalled · 2003Imx Tacrolimus II Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MLM Enzyme Immunoassay, Tracrolimus
Approved on Aug 26, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 189-day review. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 1997
- Review
- 189 days
- Class
- Class II
- Product code
- MLM
- Recalls
- 2
9 later devices descend from it, 5 citing it directly.
- This deviceP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997
- Descendant · cites it directly · 4 of its ownK070820 Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK060503 Dimension Tacr Calibrator, Model DC107Dade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK203833 Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK173857 Elecsys TacrolimusRoche Diagnostics · 2018
- Descendant · 2 generations on · 0 of its ownK150168 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension…Siemens Healthcare Diagnostics · 2015 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 2007 · cites it directly4descendants
- K060503Dimension Tacr Calibrator, Model DC107Dade Behring, Inc. · 2006 · cites it directly1descendant
- K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K173857Elecsys TacrolimusRoche Diagnostics · 2018 · 2 generations on0descendants
- K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P970007 | Imx Tacrolimus II Assay | Abbott Laboratories | 1997 | — |
| +1 | K070820 | Architect Tacrolimus: Model 1L77 | Fujirebio Diagnostics,Inc. | 2007 | 1 |
| +1 | K060503 | Dimension Tacr Calibrator, Model DC107 | Dade Behring, Inc. | 2006 | — |
| +2 | K203833 | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | 2023 | — |
| +2 | K173857 | Elecsys Tacrolimus | Roche Diagnostics | 2018 | — |
| +2 | K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus… | Siemens Healthcare Diagnostics | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 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 5.1 · 2 generations · no Class I recall
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070820 | Architect Tacrolimus: Model 1L77 | 2007 | 4 |
| K060503 | Dimension Tacr Calibrator, Model DC107 | 2006 | 1 |
| K060502 | Dimension Tacr Flex Reagent Cartridge, Model DF107 | 2006 | 0 |
| K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent | 2006 | 0 |
| K060371 | The Emit 2000 Tacrolimus Calibrators | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2003 | Not classified | Z-0230-04 | Other | Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. |
| Sep 19, 2003 | Not classified | Z-0063-04 | Other | Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070820 (Fujirebio Diagnostics,Inc., 2007) has gone furthest, with 4 descendants of its own.
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/P970007 · printed Nov 5, 2026
Cite this page
510(k) Report. “P970007: Imx Tacrolimus II Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P970007
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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