510(k) · Cleared
ClearedTacrolimus Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Genext Medical Technology Co., Ltd. · MLM Enzyme Immunoassay, Tracrolimus
Cleared on Jan 27, 2023 as substantially equivalent to K070820 (Fujirebio Diagnostics,Inc., 2007) after a 758-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 27, 2023
- Review
- 758 days
- Class
- Class II
- Product code
- MLM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P970007 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070820 | Architect Tacrolimus: Model 1L77Summary page 5…e FK506 can be calculated by measuring the absorbance at 546 nm. Substantial Equivalence Information Predicate Device Identification: ARCHITECT TACROLIMUS: MODEL lL 77 (K070820) Comparison with Predicate: Device & Predicate Candidate Device Predicate Device… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K070820.
How does its category compare?
All MLM devicesMLM Enzyme Immunoassay, Tracrolimus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
For In Vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203833: Tacrolimus Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203833
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026