# K192524: Lumipulse G CA15-3

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 4, 2020 after 357 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 K963926 (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)
- K042732: Architect CA 15-3 Assay, Fujirebio Diagnostics,Inc. (2004) Summary page 6.

## Indications for use
Lumipulse G CA15-3 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA 15-3 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in the management of patients previously diagnosed with stage II and III breast cancer. Serial testing for patient CA15-3 assay values should be used in conjunction with other clinical methods used for monitoring breast cancer. WARNING: The concentration of CA 15-3 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA 15-3 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of CA 15-3 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse G CA 15-3 should not be used for cancer screening or diagnosis.

Source page: https://510kreport.com/device/K192524
Methodology: https://510kreport.com/methodology