# K080561: Vidas CA 125 II Assay

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 10, 2009 after 407 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 K990431 (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)
- K023891: ST Aia-Pack CA 125 Enzyme Immunoassay, Tosoh Medics, Inc. (2002) Summary page 2.

## Indications for use
VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of OC 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 1I is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the detection of recurrence in previously treated ovarian cancer patients.

Source page: https://510kreport.com/device/K080561
Methodology: https://510kreport.com/methodology