510(k) · Cleared
ClearedAcs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays
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 Apr 22, 2005 as substantially equivalent to K031038 (Bayer Healthcare, LLC, 2003) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Apr 22, 2005
- Review
- 151 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010266 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK010266 Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Biosite Incorporated · 2001
- 2 generations backK031038 Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003 · Recalled
- 1 generation backK040425 Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2004
- This deviceK043228 Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 | Biosite Incorporated | 2001 | — |
| −2 | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) Assay | Bayer Healthcare, LLC | 2003 | 6 |
| −1 | K040425 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays | Bayer Healthcare, LLC | 2004 | — |
| 0 (this device) | K043228 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays | Bayer Healthcare, LLC | 2005 | — |
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? (2)
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 |
|---|---|---|---|
| * | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) AssaySummary page 2…ADVIA Centaur® BNP assay. in diagnosis an aid Centaur BNP Assay was cleared under K031 038 on June 23, 2003, as new Replacement Reagent of… | 2003 |
| * | K040425 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysSummary page 2…er the same intended 14, 2004, for the and ACS:180 BNP assays were cleared under K040425 on June other known risk assessment of severity of heart failure and for use, in conjunction with factors, to predict s… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K031038.
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 and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the…
Read the full statement (183 words)
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 and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future 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/K043228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043228: Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043228
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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