510(k) · Cleared
ClearedEmit 2000 Cyclosporine Specific Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MKW Cyclosporine
Cleared on Feb 6, 2006 as substantially equivalent to P890025 (Abbott Laboratories, 1989) after a 98-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 6, 2006
- Review
- 98 days
- Class
- Class II
- Product code
- MKW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P890025 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backP890025 TD Cyclosporine and Metabolites Serum AssayAbbott Laboratories · 1989 · Recalled
- This deviceK053061 Emit 2000 Cyclosporine Specific AssayDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P890025 | TD Cyclosporine and Metabolites Serum Assay | Abbott Laboratories | 1989 | 1 |
| 0 (this device) | K053061 | Emit 2000 Cyclosporine Specific Assay | 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 MKW? 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 |
|---|---|---|---|
| * | P890025 | TD Cyclosporine and Metabolites Serum AssaySummary page 1…Emit® 2000 Cyclosporine Specific Assay / Class 11 3. Identification of the Predicate Device Abbott TDx®/TDxELx®Cyclosporine Monoclonal Whole Blood Assay, P890025 4. Device Description The Emrit® 2000 Cyclosporine Specific Assay employs a homogeneous enzyme immunoassa… | 1989 |
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?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate P890025.
How does its category compare?
All MKW devicesMKW Cyclosporine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKW
3in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MKW
177in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKW
8in 2025
MAUDE reports naming product code MKW, 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 | 0 | — | 0 | 0 |
| 2008 | 3 | 177 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 1 | 108 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 1 | 30 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Emit® 2000 Cyclosporine Specific Assay is for in vitro quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053061: Emit 2000 Cyclosporine Specific Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053061
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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