# K031393: Bayer Advia Centaur CA 19-9 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 24, 2003 after 53 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: 8 (0 Class I)
- 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.
2 later devices descend from it; 2 cite 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)
- K020566: Fujirebio Diagnostics CA 19-9 Ria, Fujirebio Diagnostics,Inc. (2002) Summary page 3.

## Most influential descendants
- K253528: Atellica IM CA 19-9 II (2026), 0 descendants of its own
- K100375: Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension LOCI7 Calibrator with Model (S) K6457, and KC604 (2011), 0 descendants of its own

## Recalls of this device
- Jul 26, 2024 · Class II · Z-3102-2024: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The obse
- Jul 26, 2024 · Class II · Z-3103-2024: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The obse
- Jul 26, 2024 · Class II · Z-3100-2024: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The obse
- Jul 26, 2024 · Class II · Z-3101-2024: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The obse
- Jul 26, 2024 · Class II · Z-3104-2024: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The obse
- Oct 19, 2016 · Class II · Z-0612-2017: CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.
- Oct 19, 2016 · Class II · Z-0613-2017: CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.
- Nov 14, 2012 · Class II · Z-0508-2013: Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur syst

## Indications for use
The ADVIA Centaur® CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur System. 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 CA 19-9 at some point in their disease process exceeding the median concentration 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. This assay is not intended for use on any other system.

Source page: https://510kreport.com/device/K031393
Methodology: https://510kreport.com/methodology