# K022178: CA 15-3 Assay for the Advia Integrated Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Nov 12, 2002 after 132 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Immuno 1 CA 15-3: named in the summary without a submission number

## Indications for use
The Buyer ADC’IAalMS ”CA 15-3Assay is an in vitro diagnostic device intended to quantitatively measure CA 15-3 Assay values in human serum. When used in conjunction with other clinical and diagnostic procedures, serial testing with CA 15-3 Assay results are useful in monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence h previously treated Stage 11, with greater than two positive lymph nodes, or Stage III breast cancer patients.

Source page: https://510kreport.com/device/K022178
Methodology: https://510kreport.com/methodology