# K964185: IMX CA 125

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diagnostics
- Decided: Nov 4, 1997 after 379 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 4 (0 Class I)
- 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) ABBOTT CA 125 II™ RIA assay: named in the summary without a submission number

## Recalls of this device
- Nov 25, 2003 · Not classified · Z-0318-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto
- Nov 25, 2003 · Not classified · Z-0319-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto
- Nov 25, 2003 · Not classified · Z-0320-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto
- Nov 25, 2003 · Not classified · Z-0322-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto

## Indications for use
The IMx® CA 125™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 125 assay values in human serum. The IMx®. CA 125™ assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer,

Source page: https://510kreport.com/device/K964185
Methodology: https://510kreport.com/methodology