# K080194: Vidas Cea (S) Assay

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 9, 2008 after 258 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 K023893 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023893: ST Aia-Pack Cea Enzyme Immunoassay, Tosoh Medics, Inc. (2002) Summary page 2.

## Indications for use
VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.

Source page: https://510kreport.com/device/K080194
Methodology: https://510kreport.com/methodology