# K972162: Elecsys CA 125 II

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 18, 1998 after 282 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; 3 cite 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 its predicate without a number.
- (no number) Centocor® CA 125 II™ Ria: named in the summary without a submission number

## Most influential descendants
- K983875: Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products CA 125 II Reagent Pack (1999), 1 descendant of its own
- K221355: VITROS Immuodiagnostic Products CA 125 II Reagent Pack (2022), 0 descendants of its own
- K143534: Elecsys CA-125 II assay (2015), 0 descendants of its own
- K980240: Elecsys CA 125II on the Elecsys 1010 (1998), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125 II is indicated 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 diagnostic second-look procedures. The Elecsys CA 125 II is further indicated for serial measurement of CA 125 II to aid in the management of cancer patients

Source page: https://510kreport.com/device/K972162
Methodology: https://510kreport.com/methodology