510(k) · Cleared
Recalled · Class II · 2017Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NBC Test, Natriuretic Peptide
Cleared on Jun 23, 2003 as substantially equivalent to K010266 (Biosite Incorporated, 2001) after an 83-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 23, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010266 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010266 Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Biosite Incorporated · 2001
- This deviceK031038 Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 1 of its ownK192380 ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020
- Descendant · cites it directly · 1 of its ownK040425 Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2004
- Descendant · 2 generations on · 0 of its ownK211199 ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK043228 Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2005
Most influential descendants
Showing 4 of 4 · See all- K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020 · cites it directly1descendant
- K040425Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2004 · cites it directly1descendant
- K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021 · 2 generations on0descendants
- K043228Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 | Biosite Incorporated | 2001 | — |
| 0 (this device) | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) Assay | Bayer Healthcare, LLC | 2003 | — |
| +1 | K192380 | ST Aia-Pack BNP | Fujirebio Diagnostics,Inc. | 2020 | — |
| +1 | K040425 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays | Bayer Healthcare, LLC | 2004 | — |
| +2 | K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021 | — |
| +1 | K043228 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays | Bayer Healthcare, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 NBC? 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 NBC device
- #1 K262109 Access NT-proBNPscore 13.8 · 7 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 |
|---|---|---|---|
| * | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Summary page 1…ed 11030 Roselle Street San Diego, California 92121, USA 510(k) Number: K003475/K010266 Page 1 Bayer Diagnostics Corporation… | 2001 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Dec 18, 2017 | Class II | Z-2053-2018 | Device Design | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays. |
| Oct 6, 2014 | Class III | Z-0229-2015 | Labeling mix-ups | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label. |
| Jun 23, 2014 | Class II | Z-2149-2014 | Other | Complaints of failed calibration. |
| Jun 23, 2014 | Class II | Z-2150-2014 | Other | Complaints of failed calibration. |
| Nov 14, 2012 | Class II | Z-0506-2013 | 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. |
| Jul 25, 2012 | Class II | Z-2313-2012 | Nonconforming Material/Component | Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays |
The 5 latest of 6 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 NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, 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 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur@System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure. This assay is not intended for use on any other system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031038: Advia Centaur B-Type Natriuretic Peptide (BNP) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031038
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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