# K020566: Fujirebio Diagnostics CA 19-9 Ria

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 9, 2002 after 78 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
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories AxSYM® CEA MEIA: named in the summary without a submission number

## Most influential descendants
- K052000: Architect CA 19-9XR Assay (2005), 2 descendants of its own
- K031393: Bayer Advia Centaur CA 19-9 Assay (2003), 2 descendants of its own
- K191973: Lumpipulse G CA19-9-N (2019), 1 descendant of its own
- K052889: Vitros CA 19-9 (2005), 1 descendant of its own
- K253528: Atellica IM CA 19-9 II (2026), 0 descendants of its own

## Indications for use
The Fujirebio Diagnostics CA 19-9™ RIA, an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen, in human serum or plasma, is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in: Monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum or plasma CA 19-9 above the cutoff, at the time of diagnosis. CA 19-9 values must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Source page: https://510kreport.com/device/K020566
Methodology: https://510kreport.com/methodology