# K040761: Axsym Cyclosporine

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories, Inc.
- Decided: Apr 30, 2004 after 36 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 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 3.

## Indications for use
The AxSYM Cyclosporine assay is a Fluorescence Polarization Immunoassay (FPIA) in vitro reagent system for the quantitative measurement of cyclosporine (cyclosporine A) in human whole blood as an aid in the management of cardiac, liver, and renal transplant patients.

Source page: https://510kreport.com/device/K040761
Methodology: https://510kreport.com/methodology