# K023597: Access OV Monitor Immunoenzymetric Assay

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 11, 2002 after 44 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 its predicate without a number.
- (no number) Abbott Axsym CA 125 assay: named in the summary without a submission number

## Most influential descendants
- K240479: Access OV Monitor (2024), 0 descendants of its own
- K031297: Access OV Monitor Assay (2003), 0 descendants of its own

## Indications for use
The Access@ OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access@ Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Source page: https://510kreport.com/device/K023597
Methodology: https://510kreport.com/methodology