# K231517: VITROS Immunodiagnostic Products CEA Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Aug 23, 2023 after 90 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: 3 generations back to K973517 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 4.

## Indications for use
For In Vitro Diagnostic Use Only For the quantitative measurement of carcinoembryonic antigen (CEA) concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System, to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

Source page: https://510kreport.com/device/K231517
Methodology: https://510kreport.com/methodology