# K981478: Acs:Centaur Cea

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Aug 12, 1998 after 110 days
- Product code: DHX (System, Test, Carcinoembryonic Antigen)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P930017: ACS:180 CEA Immunoassay. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K200215: ADVIA Centaur CEA Assay (2020), 0 descendants of its own

## Indications for use
The Chiron Diagnostics ACS:Centaur CEA Immunoassay is for the quantitative determination of carcinoembryonic antigen in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K981478
Methodology: https://510kreport.com/methodology