# K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 25, 2008 after 379 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: 3 generations back to K981985 (1998). 4 ancestors in all.
1 later device descends 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)
- K031270: Access Cea Reagents for Use on the Access Immunoassay Systems, Beckman Coulter, Inc. (2003) Summary page 1.

## Most influential descendants
- 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 CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparin plasma on the Dimension Vista® System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed. For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Source page: https://510kreport.com/device/K071603
Methodology: https://510kreport.com/methodology