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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), an aid in 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 an aid in the risk stratification of patients with acute coronary syndromes.

The Triage® Profiler S.O.B.TM (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 peotide, 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 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 builtin control features that ensure that the test was performed properly and the reagents were functionally active.

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 myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against 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 the test was performed properly and the reagents were functionally active.

The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

This 510(k) summary (K080269) describes the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel, which are fluorescence immunoassays used with Triage Meters for the quantitative determination of various cardiac and circulatory markers in EDTA whole blood and plasma specimens.

The submission focuses on establishing substantial equivalence to a predicate device, the Biosite Triage BNP Test (K051787), particularly for the use of BNP in risk stratification of heart failure patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the Triage CardioProfilER Panel or the Triage Profiler S.O.B. Panel.

Instead, the submission states that:

• "The devices and test methods described in this Premarket Notification for the Triage CardioProfilER Panel and the Profiler S.O.B. Panel are identical in principle, reagents and procedure to their predecessors."
• "More specifically, the BNP assays included in these panels are identical to the BNP assay used in the Triage BNP Test (K051787)."
• "Therefore, the use of the Triage CardioProfilER and the Profiler S.O.B. Panels as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method."

This indicates that the acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to the previously cleared predicate device (K051787) through comparison of their identical principles, reagents, and procedures, rather than presenting new performance data against specific numerical targets.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify any sample sizes used for a test set or data provenance for a study proving device performance. The submission relies on the substantial equivalence of the new devices to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No de novo study featuring a test set with ground truth established by experts is described in the provided document.

4. Adjudication Method for the Test Set

Not applicable. No de novo study featuring a test set with adjudication is described in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The devices are diagnostic assays, not AI-assisted interpretation tools for image analysis.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The document does not describe a standalone performance study in the sense of an independent algorithm's performance. The devices are immunoassay panels that produce quantitative measurements. Their performance is indirectly addressed by claiming identity to previously-cleared assays within the predicate device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation of the new devices, as it primarily relies on substantial equivalence. For the predicate device's clearance (K051787), it would have been expected that clinical diagnosis, pathology, or patient outcomes data were used as ground truth for establishing the performance characteristics of the individual assays (CK-MB, myoglobin, troponin I, BNP, D-dimer).

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI or machine learning model that would require a "training set" in the context of typical AI device submissions. These are immunoassay panels.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no mention of a training set or its associated ground truth establishment methods for these immunoassay panels.

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