# K020828: CA 125 Assay for the Advia Centaur System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 24, 2002 after 132 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983715 (1999). 1 ancestor in all.
3 later devices descend from it; 3 cite 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)
- K983715: The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System), Bayer Corp. (1999) Summary page 1.

## Most influential descendants
- K200199: ADVIA Centaur CA 125II (2020), 0 descendants of its own
- K142895: LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (2015), 0 descendants of its own
- K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604 (2011), 0 descendants of its own

## Recalls of this device
- Feb 21, 2018 · Class II · Z-1486-2018: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
- Dec 14, 2010 · Not classified · Z-1477-2011: Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal

## Indications for use
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA CentauP System. 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 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 recomrneqded that the Bayer ADVIA Centaur CA 125 f I 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/K020828
Methodology: https://510kreport.com/methodology