510(k) · Cleared
ClearedTriage B-Type Natriuretic Peptide (BNP) Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · NBC Test, Natriuretic Peptide
Cleared on Jul 1, 2002 after a 67-day review. The FDA summary names its predicate without a number. 3 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Jul 1, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 6 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK021317 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2002
- Descendant · cites it directly · 6 of its ownK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
- Descendant · cites it directly · 4 of its ownK052789 Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · Recalled
- Descendant · 2 generations on · 3 of its ownK080269 Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK030286 Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K051787Triage BNP Test, Model 98000XRBiosite Incorporated · 2005 · cites it directly6descendants
- K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · cites it directly4descendants
- K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · 2 generations on3descendants
- K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · cites it directly3descendants
- K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021317 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2002 | — |
| +1 | K051787 | Triage BNP Test, Model 98000XR | Biosite Incorporated | 2005 | — |
| +1 | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | Biosite Incorporated | 2006 | 1 |
| +2 | K080269 | Triage Cardioprofiler and Profiler S.O.B. Panels | Biosite Incorporated | 2008 | Class I |
| +1 | K030286 | Triage Cardio Profiler/Triage Cardiac Panel | Biosite Incorporated | 2003 | Class I |
| +1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 1 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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.
3 devices in this family have a Class I recall. 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 13.9 · 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? (3)
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 |
|---|---|---|---|
| * | — | Triage BNP Test Named without a submission number | |
| * | — | Dade Stratus Cardiac Troponin-I Named without a submission number | |
| * | — | Dade Dimension RxL Cardiac Troponin4 Named without a submission number |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051787 | Triage BNP Test, Model 98000XR | 2005 | 6 |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | 2006 | 4 |
| K030286 | Triage Cardio Profiler/Triage Cardiac Panel Class I | 2003 | 3 |
| K093758 | BGM Galectin -3 | 2010 | 2 |
| K040437 | Triage Profiler S.O.B. Panel | 2004 | 2 |
| K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test | 2004 | 1 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
- K042890Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K051787 (Biosite Incorporated, 2005) has gone furthest, with 6 descendants of its own.
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?
The Triage BNP Test is intended for use with the Triage Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021317: Triage B-Type Natriuretic Peptide (BNP) Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021317
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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