# K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 17, 2004 after 30 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: 2 generations back to K973517 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990943: Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea Reagent Pack, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 2.
- K990984: Vitros Immunodiagnostic Products Cea Range Verifiers, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 2.

## Most influential descendants
- K231517: VITROS Immunodiagnostic Products CEA Reagent Pack (2023), 0 descendants of its own

## Indications for use
VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.

Source page: https://510kreport.com/device/K041322
Methodology: https://510kreport.com/methodology