# K964098: Cpa 125 II Assay for the Technicon Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Oct 31, 1997 after 385 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Centocor CA 125 II™ RIA: named in the summary without a submission number

## Indications for use
The Bayer Immuno 1™ CA 125 Il Assay is an in vitro device for the quantitative measurement of OC 125 reactive determinants associated with a high molecular glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 Il Assay is indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.” An assay value of greater than 35 U/mL is indicative of residual disease, provided that alternative causes of elevated CA 125 II Assay values can be excluded (refer to “Limitations of the Procedure” section). It is recommended that the assessment and treatment of patients with ovarian cancer and the use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.

Source page: https://510kreport.com/device/K964098
Methodology: https://510kreport.com/methodology