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Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

The proBNP II Assay is a sandwich immunoassay with two antibodies directed towards epitopes within the N-terminal portion of the proBNP molecule. The capture antibody is biotinylated to react with streptavidin-coated microparticles. The signal antibody is tagged with ruthenium. Both antibodies are monoclonal. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

Acceptance Criteria and Device Performance Study for Elecsys proBNP II STAT Immunoassay

This document describes the acceptance criteria and the study that demonstrates the Elecsys proBNP II STAT Immunoassay meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Elecsys proBNP II STAT Immunoassay are primarily demonstrated by showing substantial equivalence to the predicate device, the Elecsys proBNP II Assay (K072437), with key performance characteristics either matching or falling within acceptable ranges. The primary difference is the faster "STAT" application time and limited instrument platform.

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

• Test Set Sample Size: n = 120 patient samples were used for the method comparison study.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, based on the context of a 510(k) submission seeking equivalence to a previously approved device, these data are typically generated in controlled laboratory settings (often prospective testing of patient samples) by the manufacturer or authorized agents.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. This device is an immunoassay measuring a biomarker (NT-proBNP) quantitatively. The "ground truth" for the test set values is considered the measurements obtained by the predicate device itself, not an expert consensus on a diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this is a quantitative immunoassay comparison, there is no "adjudication" in the sense of independent expert review of cases. The comparison is statistical, comparing the results of the new device against the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks where human readers' performance is being evaluated, possibly with AI assistance. For a quantitative immunoassay, the performance is assessed by comparing its measurements to a reference method (the predicate device) and evaluating its analytical characteristics (precision, sensitivity, range).
• Effect Size of Human Readers with/without AI assistance: Not applicable.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was done for the Elecsys proBNP II STAT Assay. The "method comparison" section directly shows the performance of the new device alone against the predicate device on patient samples (n=120) and demonstrates its analytical performance characteristics (precision, analytical sensitivity, measuring range, hook effect, limitations) independently. The core of this 510(k) summary is to demonstrate that the device itself performs equivalently to the predicate to warrant a "substantially equivalent" classification.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the method comparison study was the measurements obtained from the existing, legally marketed predicate device (Elecsys proBNP II Assay, K072437). This is a common approach in 510(k) submissions for in vitro diagnostic (IVD) devices seeking substantial equivalence where a well-established predicate device exists. The predicate device's measured values are treated as the reference standard for comparison.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size in the context of typical machine learning models. This is an immunoassay, not an AI/ML-based device in the common understanding. The development and optimization of such assays typically involve iterative laboratory testing and refinement of reagents, protocols, and instrument parameters, which could be considered an internal "training" process, but not in the sense of a distinct, labeled dataset for algorithm training.

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

• Ground Truth for Training Set: Not applicable in the conventional sense of AI/ML training. The "ground truth" for developing and optimizing the assay itself would be based on established analytical chemistry principles, characterization of assay components (antibodies, calibrators), and performance against known reference materials or other validated laboratory methods. This iterative process leads to the final assay formulation and protocol, which is then formally validated using the test set described above against the predicate.

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