# K200199: ADVIA Centaur CA 125II

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Apr 6, 2020 after 70 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 K983715 (1999). 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)
- K020828: CA 125 Assay for the Advia Centaur System, Bayer Corp. (2002) Summary page 4.

## Indications for use
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125II assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

Source page: https://510kreport.com/device/K200199
Methodology: https://510kreport.com/methodology