# K981985: Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 24, 1998 after 111 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
No predicates in its family tree.
5 later devices descend from it; 3 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)
- P830066: Cea-Ria Monoclonal, Abbott Laboratories. FDA lists this PMA only through its supplements; the earliest we hold is P830066/S001 (Aug 21, 1984). Summary page 1.

## Most influential descendants
- K991707: Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206 (1999), 4 descendants of its own
- 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

## Recalls of this device
- Apr 12, 2006 · Not classified · Z-1313-06: Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.

## Indications for use
The Access® CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic antigen (CEA) in human serum using the ACCESS Immunoassay System. CEA measured by the AcCESs CEA Immunoassay, is used as an aid in the management of cancer patients.

Source page: https://510kreport.com/device/K981985
Methodology: https://510kreport.com/methodology