510(k) · Cleared
Recalled · Class II · 2020Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #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 Dec 23, 2003 after a 61-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2003
- Review
- 61 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK033383 Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model…Biosite Incorporated · 2003
- 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 · 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
- Descendant · 2 generations on · 0 of its ownK111452 Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · cites it directly4descendants
- 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
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K033383 | Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog… | Biosite Incorporated | 2003 | — |
| +1 | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | Biosite Incorporated | 2006 | 1 |
| +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 | — |
| +2 | K111452 | Presage ST2 Assay | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 13.9 · 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? (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 |
|---|---|---|---|
| * | — | Biosite Triage BNP test Named without a submission number |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Oct 1, 2020 | Class II | Z-0297-2021 | Process control | Product compromised during shipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052789 (Biosite Incorporated, 2006) has gone furthest, with 4 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 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 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/K033383 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033383: Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033383
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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