# K023208: Cedia Cyclosporine Plus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Oct 24, 2002 after 29 days
- Product code: MKW (Cyclosporine)
- Device class: 2
- Regulation: 21 CFR 862.1235
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P920031 (1996). 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)
- P920031: Emit 2000 Cyclosporine Specific Assay, Dade Behring, Inc. (1996) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K023208
Methodology: https://510kreport.com/methodology