# K051456: Sentinel Ceruloplasmin

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Oct 21, 2005 after 141 days
- Product code: JFR (Indirect Copper Assay, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Ceruloplasmin assay: named in the summary without a submission number

## Indications for use
The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.

Source page: https://510kreport.com/device/K051456
Methodology: https://510kreport.com/methodology