# K200215: ADVIA Centaur CEA Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Disgnostics, Inc.
- Decided: Apr 13, 2020 after 76 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
Longest line of descent: 1 generation back to K981478 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981478: Acs:Centaur Cea, Chiron Diagnostics Corp. (1998) Summary page 5.

## Indications for use
For in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (CEA) in serum and plasma (EDTA and lithium heparin) to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems.

Source page: https://510kreport.com/device/K200215
Methodology: https://510kreport.com/methodology