# K013984: Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Mar 28, 2002 after 115 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 2 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K233946: Immulite® 2000 BR-MA (2024), 0 descendants of its own

## Recalls of this device
- Jan 2, 2018 · Class II · Z-1691-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 
- Jan 2, 2018 · Class II · Z-1677-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
IMMULITE BR-MA For in vitro diagnostic use with IMMULITE analyzer — for the quantitative measurement of CA 15-3 antigen in human serum, 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 CA 15-3 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. IMMULITE 2000 BR-MA For in vitro diagnostic use with IMMULITE 2000 analyzer — for the quantitative measurement of CA 15-3 antigen in human serum, 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 CA 15-3 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/K013984
Methodology: https://510kreport.com/methodology