# K231525: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Aug 9, 2023 after 75 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.
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)
- K052889: Vitros CA 19-9, Fujirebio Diagnostics,Inc. (2005) Summary page 4.

## Indications for use
For in vitro diagnostic use only. For the quantitative measurement of 1116-NS‑19‑9 defined antigen in human serum and plasma (EDTA or heparin), using the VITROS 5600 Integrated System. The VITROS CA 19-9 test is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA 19-9 test 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.

Source page: https://510kreport.com/device/K231525
Methodology: https://510kreport.com/methodology