# K161508: Ceruloplasmin

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Jan 9, 2017 after 222 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
Longest line of descent: 2 generations back to K860894 (1986). 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)
- K053074: N Antisera to Human Ceruloplasmin, Dade Behring, Inc. (2006) Summary page 4.

## Indications for use
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.

Source page: https://510kreport.com/device/K161508
Methodology: https://510kreport.com/methodology