# K053074: N Antisera to Human Ceruloplasmin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 16, 2006 after 135 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: 1 generation back to K860894 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.

## Most influential descendants
- K161508: Ceruloplasmin (2017), 0 descendants of its own
- K063655: Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, Protein 1 Control High (2007), 0 descendants of its own

## Indications for use
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin aid hemopexin in serum and heparinized plasma by means of immunonephelometery the BNTM Systems. Measurement of ceruloplasmin aids in the diagnosis of copper on metabolism disorders.

Source page: https://510kreport.com/device/K053074
Methodology: https://510kreport.com/methodology