# K052889: Vitros CA 19-9

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Dec 20, 2005 after 68 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: 1 generation back to K020566 (2002). 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)
- K020566: Fujirebio Diagnostics CA 19-9 Ria, Fujirebio Diagnostics,Inc. (2002) Summary page 4.

## Most influential descendants
- K231525: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (2023), 0 descendants of its own

## Indications for use
For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin). The VITROS CA 19-9 assay is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA 19-9 assay can be used to monitor the disease status in patients with confirmed pancreatic cancer who show measurable CA 19-9 values over the course of their disease. Serial CA 19-9 test results should be used in conjunction with all other available clinical and laboratory data before a medical decision is determined. For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin). For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of 11 16-NS-19-9 defined antigen.

Source page: https://510kreport.com/device/K052889
Methodology: https://510kreport.com/methodology