# K983875: Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products CA 125 II Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 14, 1999 after 193 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972162 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K972162: Elecsys CA 125 II, Boehringer Mannheim Corp. (1998) Summary page 1.

## Most influential descendants
- K221355: VITROS Immuodiagnostic Products CA 125 II Reagent Pack (2022), 0 descendants of its own

## Recalls of this device
- Oct 9, 2013 · Class II · Z-0525-2014: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.

## Indications for use
The Vitros® CA 125 I is an in vitro assay intended for the quantitative measurement of OC 125 defined antigen in the serum or plasma (EDTA or heparin). The Vitros CA 125 1I 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 conjuction with other clinical methods used for monitoring ovarian cancer.

Source page: https://510kreport.com/device/K983875
Methodology: https://510kreport.com/methodology