# K221355: VITROS Immuodiagnostic Products CA 125 II Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Dec 12, 2022 after 216 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- 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 K972162 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983875: Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products CA 125 II Reagent Pack, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 4.

## Indications for use
For the quantitative measurement of OC 125 defined antigen concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System. The VITROS CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Source page: https://510kreport.com/device/K221355
Methodology: https://510kreport.com/methodology