# K091741: Tina-Quant Ceruloplasmin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 18, 2010 after 275 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: 2 generations back to K812486 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062114: Ceruloplasmin, Model 2055953, Roche Diagnostics Corp. (2007) Summary page 1.

## Indications for use
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K091741
Methodology: https://510kreport.com/methodology