# K071455: Advia Centaur Cyclosporine Assay and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Sep 11, 2008 after 475 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
- Jan 2, 2018 · Class II · Z-1687-2018: The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine,

## Indications for use
The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.

Source page: https://510kreport.com/device/K071455
Methodology: https://510kreport.com/methodology