# K990943: Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 1, 1999 after 71 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P830066: Cea-Ria Monoclonal, Abbott Laboratories. FDA lists this PMA only through its supplements; the earliest we hold is P830066/S001 (Aug 21, 1984). Summary page 1.

## Most influential descendants
- K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers (2004), 1 descendant of its own
- K231517: VITROS Immunodiagnostic Products CEA Reagent Pack (2023), 0 descendants of its own

## Indications for use
The Vitros® CEA is an in vitro assay intended for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum and plasma (EDTA or heparin) to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

Source page: https://510kreport.com/device/K990943
Methodology: https://510kreport.com/methodology