510(k) · Cleared
Recalled · 2011Architect Cyclosporine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · MKW Cyclosporine
Cleared on Sep 11, 2008 as substantially equivalent to P890025 (Abbott Laboratories, 1989) after a 177-day review. Its family tree reaches back 1 generation to 1989. It has been recalled once.
- Decided
- Sep 11, 2008
- Review
- 177 days
- Class
- Class II
- Product code
- MKW
- Recalls
- 1
- 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 deviceK080751 Architect CyclosporineFujirebio Diagnostics,Inc. · 2008
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) | K080751 | Architect Cyclosporine | Fujirebio Diagnostics,Inc. | 2008 | — |
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…tory Class: Class II Product Code: MKW DLJ Predicate Device ABBOTT TDx/TDxFLx Cyclosporine Monoclonal Whole Blood (P8900251 and supplement 7) Device Description The ARCHITECT Cyclosporine assay is a two-step immunoassay for the quantitative determina… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2011 | Not classified | Z-0162-2012 | Nonconforming Material/Component | The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the… |
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. 2008, this device’s year, is highlighted.
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?
Reagent Kit The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy. Calibrator Kit The ARCHITECT Cyclosporine Calibrators are for the calibration of the ARCHITECT i System when…
Read the full statement (114 words)
Reagent Kit
The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy.
Calibrator Kit
The ARCHITECT Cyclosporine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood.
Whole Blood Precipitation Reagent Kit
The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080751: Architect Cyclosporine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080751
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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