# K980887: Elecsys Cea on the Elecsys 1010

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 29, 1998 after 112 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 K964368 (1997). 2 ancestors 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)
- K964368: Elecsys Cea Assay, Boehringer Mannheim Corp. (1997) Summary page 3.

## Indications for use
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen in human serum and plasma. The Elecsys CEA assay is further indicated for serial measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay «ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K980887
Methodology: https://510kreport.com/methodology