The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes. The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters 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), an aid in the risk stratification of patients with heart failure and for the risk stratification of patients with acute coronary syndromes.
Device Story
Single-use fluorescence immunoassay panels (Triage Profiler S.O.B. and CardioProfilER) for quantitative measurement of cardiac biomarkers (CK-MB, myoglobin, troponin I, BNP, D-dimer) in EDTA whole blood or plasma. Device utilizes integrated filter for cell separation; plasma reacts with fluorescent antibody conjugates in reaction chamber; mixture flows through detection lane; analytes captured on discrete zones. Fluorescence intensity is directly proportional to analyte concentration. Operated with Triage MeterPlus. Provides rapid quantitative results to clinicians to aid in diagnosis of myocardial injury, heart failure assessment, and risk stratification for acute coronary syndromes and heart failure. No changes to test performance, design, reagents, or manufacturing; submission reflects labeling expansion for BNP prognostic utility.
Clinical Evidence
No new bench or clinical testing performed. Evidence for the expanded indication (BNP risk stratification in heart failure) relies on five peer-reviewed articles and a systematic review (Doust et al., BMJ 2005) demonstrating BNP as a strong prognostic indicator. Previous analytical and clinical performance characteristics were established in k042723 and k030286.
Technological Characteristics
Fluorescence immunoassay; uses murine monoclonal/polyclonal antibodies against CK-MB, myoglobin, troponin I, BNP, and D-dimer. Solid-phase capture with fluorescent dye labeling. Single-use test device with integrated filtration. Quantitative measurement via Triage MeterPlus. No changes to materials or energy source.
Indications for Use
Indicated for patients suspected of myocardial infarction, heart failure, disseminated intravascular coagulation, thromboembolic events (including pulmonary embolism), or acute coronary syndromes. Used for diagnosis, assessment of heart failure severity, and risk stratification.
Regulatory Classification
Identification
The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.
Special Controls
*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Predicate Devices
Triage® BNP Test (k051787)
Triage® Profiler S.O.B. Panel (k042723)
Triage® CardioProfilER® Panel (k030286)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k080269
B. Purpose for Submission:
Modification to the Triage® Profiler S.O.B. Panel (k040437) and the Triage® Cardio ProfilER Panel (k030286) to expand the portion of the Indications for Use statement pertaining to the BNP Test to add “as an aid in the risk stratification of patients with heart failure” and labeling revisions to BNP portion of the labeling to include a section titled “Prognostic Utility in Patients with Heart Failure.” The identical changes to the Indications for Use and the labeling revisions to the “Prognostic Utility in Patients with Heart Failure” section of the labeling were cleared for the Triage® BNP Test in k051787. There have been no changes to the test performance, design, reagents and manufacture. No changes have been made to the D-Dimer, Troponin I, CK-MB and Myoglobin assays.
C. Measurand:
B-type Natriuretic Peptide (BNP)
D-Dimer
CK-MB
Troponin I
Myoglobin
D. Type of Test:
Quantitative fluorescence immunoassay
E. Applicant:
Biosite Incorporated
F. Proprietary and Established Names:
Triage® Profiler S.O.B.™ (Shortness of Breath Panel)
Triage® CardioProfilER® Panel
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G. Regulatory Information:
1. Regulation section:
21 CFR 862.1117, Test, Natriuretic Peptide
21 CFR 864.7320, Fibrinogen/fibrin degradation products assay
21 CFR 862.1215, Immunoassay Method, Troponin Subunit
21 CFR 862.1215, Fluorometric method, CPK or isoenzymes
21 CFR 866.5680, Myoglobin, antigen, antiserum, control
2. Classification:
Class II
3. Product code:
NBC, DAP, MMI, JHX, DDR
4. Panel:
81 Hematology, 75 Chemistry, 82 Immunology
H. Intended Use:
1. Intended use(s):
See Indications for Use below
2. Indication(s) for use:
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.
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The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters 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), an aid in the risk stratification of patients with heart failure and for the risk stratification of patients with acute coronary syndromes.
3. Special conditions for use statement(s):
The device is for prescription use
4. Special instrument requirements:
Triage MeterPlus
I. Device Description:
The Triage® Profiler S.O.B. test device contains all the reagents necessary for the simultaneous quantification of D-dimer, CK-MB, myoglobin, troponin I and BNP in whole blood and EDTA plasma samples. The Triage® Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I, murine monoclonal antibodies to D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active.
The Triage® Cardio ProfilER test device contains all the reagents necessary for the simultaneous quantification of CK-MB, myoglobin, troponin I and BNP in whole blood and EDTA plasma samples. The Triage® Cardio ProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Triage® BNP Test
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Triage® Profiler S.O.B. Panel
Triage® CardioProfilER® Panel
2. Predicate K number(s):
k051787
k042723
k030286
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | k080269 | k051787 |
| Test principle, procedure and reagents | Same | Same |
| Indications for Use | Use of BNP as an aid in the: Diagnosis of heart failure Assessment of severity of heart failure Risk stratification of patients with acute coronary syndromes Risk stratification of patients with heart failure | Same |
| Differences | | |
| --- | --- | --- |
| Item | k080269 | k030286/k042723 |
| Indications for Use | Use of BNP as an aid in the: Diagnosis of heart failure Assessment of severity of | Use of BNP as an aid in the: Diagnosis of heart failure Assessment of severity of |
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| Differences | | |
| --- | --- | --- |
| Item | k080269 | k030286/k042723 |
| | Assessment of severity of heart failure
Risk stratification of patients with acute coronary syndromes
Risk stratification of patients with heart failure | heart failure
Risk stratification of patients with acute coronary syndromes |
## K. Standard/Guidance Document Referenced (if applicable):
None referenced
## L. Test Principle:
The Triage® Profiler S.O.B. Panel is a fluorescence immunoassay for the quantitative determination of D-dimer, CK-MB, myoglobin, troponin I, and BNP in whole blood and plasma specimens using EDTA as the anticoagulant. After addition of the sample to the sample port, the cells are separated from the plasma via a filter contained in the device. A predetermined quantity of plasma is allowed to react with fluorescent antibody conjugates within the reaction chamber. After sufficient incubation has occurred, the reaction mixture flows down the device detection lane. Complexes of the analytes and fluorescent antibody conjugates are captured on discrete zones resulting in binding assays that are specific for each analyte. The concentration of the analyte in the specimen is directly proportional to the fluorescence detected.
The Triage® CardioProfilER Panel is a fluorescence immunoassay for the quantitative determination of CK-MB, myoglobin, troponin I, and BNP in whole blood and plasma specimens using EDTA as the anticoagulant. After addition of the sample to the sample port, the cells are separated from the plasma via a filter contained in the device. A predetermined quantity of plasma is allowed to react with fluorescent antibody conjugates within the reaction chamber. After sufficient incubation has occurred, the reaction mixture flows down the device detection lane. Complexes of the analytes and fluorescent antibody conjugates are captured on discrete zones resulting in binding assays that are specific for each analyte. The concentration of the analyte in the specimen is directly proportional to the fluorescence detected.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
b. Linearity/assay reportable range:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
d. Detection limit:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
e. Analytical specificity:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
f. Assay cut-off:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
2. Comparison studies:
a. Method comparison with predicate device:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
b. Matrix comparison:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
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3. Clinical studies:
a. Clinical Sensitivity:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
b. Clinical specificity:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
c. Other clinical supportive data (when a. and b. are not applicable):
The changes to the portion of the Indications for Use pertaining to BNP and the labeling revisions to the “Prognostic Utility in Patients with Heart Failure” section of the labeling were cleared for the Triage® BNP Test in k051787.
To support the additional intended use, the sponsor provided five peer-reviewed articles from the scientific literature assessing the clinical utility of BNP measurements as an aid in the risk stratification of patients with heart failure. All five studies utilized the Biosite Triage BNP device in their test method.
In one additional paper titled “How well does B-type natriuretic peptide predict death and cardiac events in patients with heart failure: systematic review,” J.A. Doust et al. (British Medical Journal, volume 330, 19 March 2005) performed a systematic evidence-based medicine review of the literature. The review included 24 studies in all. While the review included studies with different study designs and test methods (BNP and NT-proBNP), the five articles previously mentioned were part of the review. The authors concluded that BNP was a strong prognostic indicator for patients with heart failure.
All literature references are cited in the sponsor’s labeling.
4. Clinical cut-off:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
5. Expected values/Reference range:
Previously demonstrated for Triage® Profiler S.O.B. Panel in k042723 and Triage® CardioProfilER® Panel in k030286.
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N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
8
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
