510(k) · Cleared
Recalled · Class II · 2017Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MLM Enzyme Immunoassay, Tracrolimus
Cleared on Apr 6, 2006 as substantially equivalent to P970007 (Abbott Laboratories, 1997) after a 51-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Apr 6, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- MLM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to P970007 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
- This deviceK060385 Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P970007 | Imx Tacrolimus II Assay | Abbott Laboratories | 1997 | 2 |
| 0 (this device) | K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent | Dade Behring, Inc. | 2006 | — |
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 5.0 · 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 |
|---|---|---|---|
| * | P970007 | Imx Tacrolimus II AssaySummary page 1…000 Tacrolimus Sample Pretreatment Reagent / Class II 3. Identification of the Predicate Device Abbott IMx® Tacrolimus II Assay and Pretreatment Reagent, P970007 (Note: Tacrolimus test systems have been reclassified into Class 11 since the predicate was approved.) === Page… | 1997 |
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 |
|---|---|---|---|---|
| Jun 29, 2017 | Class II | Z-1661-2018 | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate P970007.
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 Emit® 2000 Tacrolimus Assay is for in vitro quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients.
The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060385: Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060385
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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