510(k) · Cleared
Recalled · Class II · 2020Bayer Advia Centaur Her-2/Neu Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · NCW System, Test, Her-2/Neu, Monitoring
Cleared on Jan 30, 2003 as substantially equivalent to K992228 (Bayer Corp., 2000) after a 57-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Jan 30, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- NCW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992228 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK992228 Bayer Immuno 1 Her-2/Neu AssayBayer Corp. · 2000
- This deviceK024017 Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992228 | Bayer Immuno 1 Her-2/Neu Assay | Bayer Corp. | 2000 | — |
| 0 (this device) | K024017 | Bayer Advia Centaur Her-2/Neu Assay | Bayer Corp. | 2003 | — |
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 NCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K992228 | Bayer Immuno 1 Her-2/Neu AssaySummary page 1…on of Tumor Associated Antigen Premarket Notifications”. Substantial Equivalence To: Bayer Immuno-1 HER-2heu 510(k) Number: K992228 Page 2 of 2 7.2 Intended U… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2020 | Class II | Z-0115-2021 | Process control | Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NCW devicesNCW System, Test, Her-2/Neu, Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NCW
FDA has decided no NCW device since 2007.
Median 510(k) review, days · NCW
Too few NCW 510(k)s in any year since 2007 to give a median.
Recalls per year · NCW
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NCW
No MAUDE report names NCW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast…
Read the full statement (124 words)
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024017 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024017: Bayer Advia Centaur Her-2/Neu Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024017
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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