510(k) · Cleared
Recalled · Class II · 2014Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200
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 Jan 23, 2006 as substantially equivalent to K033383 (Biosite Incorporated, 2003) and 2 other predicates after a 112-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 23, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN000010 (2000). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 3 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 2 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 1 generation backK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
- This deviceK052789 Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006
- Descendant · cites it directly · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK111452 Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · cites it directly2descendants
- K252169Access BNP IIBeckman Coulter, Inc. · 2026 · cites it directly0descendants
- K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc. · 2014 · 2 generations on0descendants
- K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −3 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −2 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K051787 | Triage BNP Test, Model 98000XR | Biosite Incorporated | 2005 | — |
| 0 (this device) | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | Biosite Incorporated | 2006 | — |
| +1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
| +1 | K252169 | Access BNP II | Beckman Coulter, Inc. | 2026 | — |
| +2 | K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT… | Fujirebio Diagnostics,Inc. | 2014 | — |
| +2 | K111452 | Presage ST2 Assay | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K033383 | Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200Summary page 1…Triage® BNP Test for the Beckman Coulter Immunoassay Systems C. Predicate Devices Biosite Triage BNP Test for the Beckman Coulter Immunoassay Systems (K033383) Biosite Triage BNP Test (K021317 and KO0i1787) D. Device Description and Intended Use The Triage BNP test is in… | 2003 |
| * | K021317 | Triage B-Type Natriuretic Peptide (BNP) TestSummary page 1…er Immunoassay Systems C. Predicate Devices Biosite Triage BNP Test for the Beckman Coulter Immunoassay Systems (K033383) Biosite Triage BNP Test (K021317 and KO0i1787) D. Device Description and Intended Use The Triage BNP test is intended for use with Beckman Coulter… | 2002 |
| * | K051787 | Triage BNP Test, Model 98000XRSummary page 2…nts and procedure to its predecessor, the currently marketed Triage BNP Test for the Beckman Coulter Immunoassay (K033383). Moreover, the Triage BNP Test (K051787) serves as the predicate method for the use of a circulating biomarker to provide prognostic information in patients wi… | 2005 |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Mar 20, 2014 | Class II | Z-1540-2014 | Under Investigation by firm | These lots may not recover within range when tested using certain commercially available controls. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K093758 (Bg Medicine, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K033383.
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 Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052789
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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