# K012357: CA 15-3 Assay for the Advia Centaur System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Feb 28, 2002 after 218 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 K964703 (1997). 1 ancestor in all.
3 later devices descend from it; 2 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)
- K964703: The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System), Bayer Corp. (1997) Summary page 1.

## Most influential descendants
- K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605 (2011), 1 descendant of its own
- K192777: ADVIA Centaur CA 15-3 assay (2019), 0 descendants of its own
- K122398: Rapidpoint 500 System Measurement Cartridge with Calibrators (2012), 0 descendants of its own

## Indications for use
The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum using the ADVIA Centaur® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated patients with Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended for use on any other system.

Source page: https://510kreport.com/device/K012357
Methodology: https://510kreport.com/methodology