# K991707: Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206

- Pathway: 510(k) (Special)
- Applicant: Beckman
- Decided: Jun 1, 1999 after 13 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 K981985 (1998). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K031270: Access Cea Reagents for Use on the Access Immunoassay Systems (2003), 2 descendants of its own
- K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) (2008), 1 descendant of its own
- K223921: Access CEA (2023), 0 descendants 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

## 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 System. CEA measured by the Access Immunoassay System 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/K991707
Methodology: https://510kreport.com/methodology