510(k) · Cleared
ClearedTriage BNP Test, Model 98000XR
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 Sep 22, 2005 as substantially equivalent to K021317 (Biosite Incorporated, 2002) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 2000. 1 of the 11 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 22, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN000010 (2000). 4 ancestors in all. 6 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 2 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 1 generation backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- This deviceK051787 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 · cites it directly · 3 of its ownK080269 Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK252169 Access BNP IIBeckman Coulter, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK140436 ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS…Fujirebio Diagnostics,Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080269 Triage Cardioprofiler and Profiler S.O.B. Panelscites it directly · 2008
Most influential descendants
Showing 5 of 6 · See all- 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 · cites it directly3descendants
- K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · cites it directly2descendants
- K252169Access BNP IIBeckman Coulter, Inc. · 2026 · 2 generations on0descendants
- K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −2 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −1 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | 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 |
| +1 | K080269 | Triage Cardioprofiler and Profiler S.O.B. Panels | Biosite Incorporated | 2008 | Class I |
| +1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
| +2 | K252169 | Access BNP II | Beckman Coulter, Inc. | 2026 | — |
| +2 | K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT… | Fujirebio Diagnostics,Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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.
1 device in this family has 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 13.8 · 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 |
|---|---|---|---|
| * | K021317 | Triage B-Type Natriuretic Peptide (BNP) TestSummary page 1…R. Dahlen, Ph.D. Date Summary Prepared: September 17, 2005 B. Product Triage® BNP Test C. Predicate Devices Biosite Triage BNP Test (K021317) Roche Elecsys ProBNP Immunoassay (K032646) D. Device Description and Intended Use The Triage BNP Test is a rapid,… | 2002 |
| * | K032646 | Elecsys Probnp ImmunoassaySummary page 1…September 17, 2005 B. Product Triage® BNP Test C. Predicate Devices Biosite Triage BNP Test (K021317) Roche Elecsys ProBNP Immunoassay (K032646) D. Device Description and Intended Use The Triage BNP Test is a rapid, point of care fluorescence immunoassay to… | 2003 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052789 (Biosite Incorporated, 2006) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K021317.
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 a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the:
* Diagnosis of heart failure
* Assessment of heart failure severity of
* Risk stratification of patients with acute coronary syndromes
* Risk stratification of patients with heart failure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051787: Triage BNP Test, Model 98000XR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051787
Report an extraction error
Are you the manufacturer?
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