510(k) · Cleared
ClearedCedia Cyclosporine Plus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · MKW Cyclosporine
Cleared on Oct 24, 2002 as substantially equivalent to P920031 (Dade Behring, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 24, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- MKW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P920031 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backP920031 Emit 2000 Cyclosporine Specific AssayDade Behring, Inc. · 1996
- This deviceK023208 Cedia Cyclosporine Plus AssayMicrogenics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P920031 | Emit 2000 Cyclosporine Specific Assay | Dade Behring, Inc. | 1996 | — |
| 0 (this device) | K023208 | Cedia Cyclosporine Plus Assay | Microgenics Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | P920031 | Emit 2000 Cyclosporine Specific AssaySummary page 1…EDIA Cyclosporine Plus Assay is substantially equivalent to EMIT 2000 Cyclosporine Specific Assay (Dade Behring Inc., San Jose, CA), cleared under premarket notification P92003 1 CEDIA Cyclosporine Plus Assay is identical or similar to its predicate in terms of intended use, method principle, device compone… | 1996 |
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 no recall.
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 CEDIA Cyclosporine Plus Assay is for the quantitative determination of
cyclosporine in human whole blood using automated clinical chemistry analyzers as an
aid in the management of therapy in kidney, liver, and heart transplants. The CEDIA
Cyclosporine Calibrators are used to calibrate the CEDIA Cyclosporine Plus Assay in
human whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023208: Cedia Cyclosporine Plus Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023208
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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