# K963803: Centocor CA 15-3 Ria Model NO. 800-033

- Pathway: 510(k) (Traditional)
- Applicant: Centocor, Inc.
- Decided: May 23, 1997 after 242 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: 1 generation back to P950011 (1996). 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)
- P950011: Truquant (R) BR (TM) Ria, Biomira, Inc. (1996) Summary page 2.

## Most influential descendants
- K983690: Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA 15-3 Reagent Pack (1999), 0 descendants of its own

## Indications for use
The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibody-defined antigen, encoded by the MUC 1 gene, in serum and plasma. Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage II or stage ITI breast cancer, who are clinically free of discase. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures

Source page: https://510kreport.com/device/K963803
Methodology: https://510kreport.com/methodology