# K240403: Access BR Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 9, 2024 after 90 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: 3 generations back to K963926 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647, Beckman Coulter, Inc. (2007) Summary page 4.
- K033036: BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647, Beckman Coulter, Inc. (2004) Summary page 4.

## Indications for use
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

Source page: https://510kreport.com/device/K240403
Methodology: https://510kreport.com/methodology