510(k) · Cleared
Recalled · Class I · 2023Triage Cardio Profiler/Triage Cardiac Panel
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 Feb 21, 2003 as substantially equivalent to K973126 (Biosite Incorporated, 1997) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1997. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Feb 21, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 3 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973126 (1997). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK973126 Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage…Biosite Incorporated · 1997
- This deviceK030286 Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003
- Descendant · cites it directly · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
- 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 3 of 3 · See all- K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · cites it directly2descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K973126 | Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin… | Biosite Incorporated | 1997 | — |
| 0 (this device) | K030286 | Triage Cardio Profiler/Triage Cardiac Panel | Biosite Incorporated | 2003 | — |
| +1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K973126 | Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage…Summary page 1…Test, Natriuretic Peptide (862.1 117) (Triage@Cardio ProfiIER) Product Code NBC C. Predicate Devices Triage@Cardiac Panel (K973126) ” y Triage@BNP Test… | 1997 |
| * | K021317 | Triage B-Type Natriuretic Peptide (BNP) Test | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093758 | BGM Galectin -3 | 2010 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2023 | Class I | Z-1974-2023 | Nonconforming Material/Component | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if… |
| May 22, 2012 | Class I | Z-1929-2012 | Process design | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false… |
| Apr 27, 2009 | Not classified | Z-1391-2009 | Process control | The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis. |
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?
The Triage@ Cardio ProfilER is a fluorescence immunoassay to be used with the Triage@Meter for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification…
Read the full statement (123 words)
The Triage@ Cardio ProfilER is a fluorescence immunoassay to be used with the Triage@Meter for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.
The Triage03 Cardiac Panel is a fluorescence immunoassay to be used with the Triage@Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030286: Triage Cardio Profiler/Triage Cardiac Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030286
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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