# P890025: TD Cyclosporine and Metabolites Serum Assay

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Dec 14, 1989 after 248 days
- Product code: MGU (Fluorescence Polarization Immunoassay For 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
No predicates in its family tree.
8 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K052017: Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108 (2005), 1 descendant of its own
- K023065: Cyclosporine (Csa) Flex Reagent Cartridge (2002), 1 descendant of its own
- K071455: Advia Centaur Cyclosporine Assay and Calibrator (2008), 0 descendants of its own
- K080751: Architect Cyclosporine (2008), 0 descendants of its own
- K081992: Dimension Vista Csae Flex Regent Cartridge, Model K4108 (2008), 0 descendants of its own

## Recalls of this device
- Mar 23, 2005 · Not classified · Z-0624-06: Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important P

Source page: https://510kreport.com/device/P890025
Methodology: https://510kreport.com/methodology