# K080751: Architect Cyclosporine

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 11, 2008 after 177 days
- Product code: MKW (Cyclosporine)
- Device class: 2
- Regulation: 21 CFR 862.1235
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P890025 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890025: TD Cyclosporine and Metabolites Serum Assay, Abbott Laboratories (1989) Summary page 1.

## Recalls of this device
- Oct 7, 2011 · Not classified · Z-0162-2012: 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. Calibrat

## Indications for use
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.

Source page: https://510kreport.com/device/K080751
Methodology: https://510kreport.com/methodology