# K253528: Atellica IM CA 19-9 II

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 10, 2026 after 270 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)
- K031393: Bayer Advia Centaur CA 19-9 Assay, Bayer Healthcare, LLC (2003) Summary page 7.

## Indications for use
The Atellica IM CA 19-9 II (CA 19-9 II) assay is an in vitro diagnostic immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. This assay 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 at some point in their disease process exceeding the upper limit of normal determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.

Source page: https://510kreport.com/device/K253528
Methodology: https://510kreport.com/methodology