# K980855: Immulite 2000 Carcinoembryonic Antigen (Cea) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dpc Cirrus
- Decided: Apr 21, 1998 after 47 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1679-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.

Source page: https://510kreport.com/device/K980855
Methodology: https://510kreport.com/methodology