# K964368: Elecsys Cea Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 16, 1997 after 227 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860058: Enzymun Test{R} Cea, Boehringer Mannheim Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P860058/S001 (Jul 29, 1993). Summary page 1.

## Most influential descendants
- K980887: Elecsys Cea on the Elecsys 1010 (1998), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma. Measurements of CEA aid in the management of cancer patients by monitoring CEA concentrations. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Source page: https://510kreport.com/device/K964368
Methodology: https://510kreport.com/methodology