← Product Code [NBC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBC) · K080269 # TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (K080269) _Biosite Incorporated · NBC · Jun 6, 2008 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBC/K080269 ## Device Facts - **Applicant:** Biosite Incorporated - **Product Code:** [NBC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBC.md) - **Decision Date:** Jun 6, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1117 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications 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. 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 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 {1} 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. {2} 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 {3} 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 | {4} | 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. {5} 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. {6} 7 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. {7} 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBC/K080269](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBC/K080269) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com