# K983715: The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: May 14, 1999 after 205 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
No predicates in its family tree.
4 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K020828: CA 125 Assay for the Advia Centaur System (2002), 3 descendants of its own
- 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

## Indications for use
The Bayer Immuno 1™ CA 125II Assay is an in vitro device for the quantitative measurement of OC 125 determinants associated with a high molecular weight glycoprotein in serum of women with epithelial invasive ovarian cancer. The Bayer Immuno 1™ CA 125II Assay is indicated as a one time test for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for second-look procedures. An assay value greater than 35 U/mL is predictive of residual disease provided alternative causes of an elevated CA 125II value can be excluded. The Bayer Immuno 1™ CA 125II Assay is further indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostic procedures. It is recommended that the Bayer Immuno 1™ CA 125II Assay be used under the order of a physician trained and experienced in 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/K983715
Methodology: https://510kreport.com/methodology