# K191973: Lumpipulse G CA19-9-N

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Dianostics, Inc.
- Decided: Oct 22, 2019 after 90 days
- Product code: NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer)
- 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 K020566 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052000: Architect CA 19-9XR Assay, Fujirebio Diagnostics,Inc. (2005) Summary page 6.

## Most influential descendants
- K200997: Lumipulse G CA19-9-N (2020), 0 descendants of its own

## Indications for use
Lumipulse G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA19-9 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 diagnosed with cancer of the exocrine pancreas who have detectable levels of CA19-9 at some point in their disease process. Serial testing for patient CA19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas. WARNING: The concentration of CA19-9 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 CA19-9 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 CA19-9 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 CA19-9-N should not be used for cancer screening or diagnosis. WARNING: Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA19-9 based on gene dosage effect.

Source page: https://510kreport.com/device/K191973
Methodology: https://510kreport.com/methodology