# K970877: Immulite Cea

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Sep 22, 1997 after 196 days
- Product code: DHX (System, Test, Carcinoembryonic Antigen)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 3 (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. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories' IMx® CEA: named in the summary without a submission number

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1678-2018: 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 
- May 26, 2005 · Not classified · Z-1015-05: Adverse trend in stability, controls biased or out of range.
- May 3, 2004 · Not classified · Z-0972-04: Instabililty

## Indications for use
DPC's IMMULITE CEA is intended for use with the IMMULITE Automated Immunoassay Analyzer. The IMMULITE CEA is a solid-phase, chemiluminescent enzyme immunoassay designed for the quantitative detection of carcinoembryonic antigen in human serum. It is intended strictly 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/K970877
Methodology: https://510kreport.com/methodology