# K983690: Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA 15-3 Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Feb 2, 1999 after 104 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- 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 P950011 (1996). 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)
- K963803: Centocor CA 15-3 Ria Model NO. 800-033, Centocor, Inc. (1997) Summary page 1.

## Indications for use
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression se to treatment.

Source page: https://510kreport.com/device/K983690
Methodology: https://510kreport.com/methodology