# K013568: Cea Assay for the Advia Integrated Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 21, 2001 after 56 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.
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. 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
- P940030: Immuno 1 CEA Assay. 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.

## Indications for use
The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to quantitatively measure carcinoembryonic antigen (CEA) in human serum. CEA test results aid in the management of cancer patients by monitoring CEA concentrations. CEA testing is not recommended as a screening procedure to detect cancer in the general population.

Source page: https://510kreport.com/device/K013568
Methodology: https://510kreport.com/methodology