# K990774: Abbott Architect Cea

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 11, 1999 after 63 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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 AxSYM CEA assay: named in the summary without a submission number

## Most influential descendants
- K100831: Cyfra 21-1 Eia Model 211-10 (2011), 3 descendants of its own
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), 1 descendant of its own
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own
- K222251: B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC (2023), 0 descendants of its own
- K202852: DiviTum TKa (2022), 0 descendants of its own

## Indications for use
The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

Source page: https://510kreport.com/device/K990774
Methodology: https://510kreport.com/methodology