# K062114: Ceruloplasmin, Model 2055953

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 31, 2007 after 191 days
- Product code: CHN (Immunochemical, Ceruloplasmin)
- Device class: 2
- Regulation: 21 CFR 866.5210
- 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 K812486 (1981). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812486: Immunogl. FRCT. of Rabbit Antiser.-Cerul, Dako Corp. (1981) Summary page 2.

## Most influential descendants
- K091741: Tina-Quant Ceruloplasmin (2010), 0 descendants of its own

## Indications for use
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems. Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders. In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Source page: https://510kreport.com/device/K062114
Methodology: https://510kreport.com/methodology