510(k) · Cleared
ClearedCedia Tacrolimus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · MLM Enzyme Immunoassay, Tracrolimus
Cleared on Mar 15, 2005 after a 46-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 15, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- MLM
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Top candidate predicates for a new MLM device
- #1 K203833 Tacrolimus Assay Kitscore 5.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | IMx® Tacrolimus II (MEIA) Named without a submission number |
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.
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 | — |
What is it indicated for?
The CEDIA® Tacrolimus Assay is an in vitro diagnostic device intended for use with automated clinical chemistry analyzers for the quantitative determination of tacrolimus in human whole blood as an aid in the management of kidney and liver transplant recipients receiving tacrolimus therapy.
CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050206: Cedia Tacrolimus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050206
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026