510(k) · Cleared
Recalled · Class II · 2024Bayer Advia Centaur CA 19-9 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Cleared on Jun 24, 2003 as substantially equivalent to K020566 (Fujirebio Diagnostics,Inc., 2002) after a 53-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 24, 2003
- Review
- 53 days
- Class
- Class II
- Product code
- NIG
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020566 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020566 Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 2002
- This deviceK031393 Bayer Advia Centaur CA 19-9 AssayBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 0 of its ownK253528 Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK100375 Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension…Siemens Healthcare Diagnostics, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020566 | Fujirebio Diagnostics CA 19-9 Ria | Fujirebio Diagnostics,Inc. | 2002 | — |
| 0 (this device) | K031393 | Bayer Advia Centaur CA 19-9 Assay | Bayer Healthcare, LLC | 2003 | — |
| +1 | K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
| +1 | K100375 | Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension LOCI7… | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NIG device
- #1 K253528 Atellica IM CA 19-9 IIscore 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020566 | Fujirebio Diagnostics CA 19-9 RiaSummary page 3…em. 6. Substantial Equivalence The ADVIA Centaur CA 19-9 Assay is substantially equivalent to the Fujirebio Diagnostics CA 19-9 RIA predicate device cleared under K020566. Both products are based on the use of the same monoclonal antibody (Mab), 1116NS19-9, which is intended for use in the qua… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2024 | Class II | Z-3102-2024 | Under Investigation by firm | 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 observed bias is not proportional across… |
| Jul 26, 2024 | Class II | Z-3103-2024 | Under Investigation by firm | 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 observed bias is not proportional across… |
| Jul 26, 2024 | Class II | Z-3100-2024 | Under Investigation by firm | 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 observed bias is not proportional across… |
| Jul 26, 2024 | Class II | Z-3101-2024 | Under Investigation by firm | 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 observed bias is not proportional across… |
| Jul 26, 2024 | Class II | Z-3104-2024 | Under Investigation by firm | 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 observed bias is not proportional across… |
| Oct 19, 2016 | Class II | Z-0612-2017 | Process design | 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 | Process design | 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 | Device Design | 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 system used. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NIG devicesNIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIG
Too few NIG 510(k)s in any year since 2007 to give a median.
Recalls per year · NIG
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIG
98in 2025
MAUDE reports naming product code NIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 1 | — | 1 | 8 |
| 2012 | 0 | — | 1 | 1,785 |
| 2013 | 0 | — | 0 | 182 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 2 | 69 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 135 |
| 2020 | 1 | — | 0 | 93 |
| 2021 | 0 | — | 0 | 69 |
| 2022 | 0 | — | 0 | 83 |
| 2023 | 1 | — | 0 | 129 |
| 2024 | 0 | — | 0 | 121 |
| 2025 | 0 | — | 0 | 98 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031393: Bayer Advia Centaur CA 19-9 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026