# K233946: Immulite® 2000 BR-MA

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products, Ltd.
- Decided: Mar 13, 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: 2 generations back to K964703 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013984: Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR, Diagnostic Products Corp. (2002) Summary page 4.

## Indications for use
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of CA15-3 antigen in human serum and plasma, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in stage II and stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

Source page: https://510kreport.com/device/K233946
Methodology: https://510kreport.com/methodology