# K031270: Access Cea Reagents for Use on the Access Immunoassay Systems

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: May 6, 2003 after 15 days
- Product code: DHX (System, Test, Carcinoembryonic Antigen)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981985: Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209, Beckman Coulter, Inc. (1998) Summary page 1.
- K991707: Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206, Beckman (1999) Summary page 1.
- (no number) Access 2: named in the summary without a submission number

## Most influential descendants
- K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) (2008), 1 descendant of its own
- K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604 (2011), 0 descendants of its own

## Recalls of this device
- Oct 13, 2015 · Class II · Z-0239-2016: Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

## 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/K031270
Methodology: https://510kreport.com/methodology