# K033036: BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 3, 2004 after 127 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963926 (1997). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963926: Axsym CA 15-3, Abbott Laboratories (1997) Summary page 1.

## Most influential descendants
- K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647 (2007), 3 descendants of its own
- 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
- K240403: Access BR Monitor (2024), 0 descendants of its own
- K122398: Rapidpoint 500 System Measurement Cartridge with Calibrators (2012), 0 descendants of its own

## Recalls of this device
- Apr 13, 2017 · Class II · Z-2074-2017: Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit

## 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 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 patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

Source page: https://510kreport.com/device/K033036
Methodology: https://510kreport.com/methodology