# K223921: Access CEA

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 22, 2023 after 267 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: 2 generations back to K981985 (1998). 3 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)
- K991707: Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206, Beckman (1999) Summary page 4.
- K981985: Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209, Beckman Coulter, Inc. (1998) Summary page 4.

## Indications for use
The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

Source page: https://510kreport.com/device/K223921
Methodology: https://510kreport.com/methodology