# K122965: Human Caeruloplasmin Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jun 3, 2013 after 252 days
- Product code: DDB (Ceruloplasmin, Antigen, Antiserum, Control)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Human Ceruloplasmin Kit for use on SPApys is intended for the quantitative /n vitro measurement of human ceruloplasmin in serum using the SPApys turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K122965
Methodology: https://510kreport.com/methodology