510(k) · Cleared
ClearedAbbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · NBC Test, Natriuretic Peptide
Cleared on Jan 30, 2004 as substantially equivalent to K021317 (Biosite Incorporated, 2002) after a 74-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Jan 30, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021317 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK021317 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2002
- This deviceK033606 Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme…Axis-Shield Diagnostics, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK060964 Architect BNP Assay, Model 8K28Fujirebio Diagnostics,Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K060964Architect BNP Assay, Model 8K28Fujirebio Diagnostics,Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021317 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2002 | — |
| 0 (this device) | K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay… | Axis-Shield Diagnostics, Ltd. | 2004 | — |
| +1 | K060964 | Architect BNP Assay, Model 8K28 | Fujirebio Diagnostics,Inc. | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K021317 | Triage B-Type Natriuretic Peptide (BNP) TestSummary page 2…510(k) Summary Substantial equivalence The AxSYM BNP immunoassay is substantially equivalent to the Biosite Triage BNP Test cleared under K021317. Both products are intended for use in the quantitative determination of B-type natriuretic peptide. Substantial equivalence -… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060964 | Architect BNP Assay, Model 8K28 | 2006 | 0 |
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?
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?
AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033606: Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033606
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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