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Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.

Here's a breakdown of the acceptance criteria and study details for the Stratus® CK-MB Fluorometric Enzyme Immunoassay, based on the provided document:

Acceptance Criteria and Device Performance Study

The primary purpose of this submission (K972782) was to expand the sample type for the already cleared Stratus® CK-MB Fluorometric Enzyme Immunoassay from human serum to human heparinized plasma samples. The acceptance criteria for this expansion focused on demonstrating substantial equivalence between the performance of the assay when using serum compared to heparinized plasma.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state pre-defined acceptance criteria in terms of specific ranges for slope, intercept, or correlation coefficient. Instead, it presents the results of a comparison study between serum and heparinized plasma, implying that acceptable performance is demonstrated by a strong correlation and a slope/intercept close to the ideal (slope of 1, intercept of 0) for method comparison.

Note: The "Acceptance Criteria" here are inferred based on typical expectations for method comparison studies to demonstrate substantial equivalence for a new sample type. The document does not explicitly state what ranges were considered acceptable prior to the study.

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

• Sample Size: 160 samples (referred to as "rats" in the table, which is highly likely a typo and should be "runs" or "samples"). Given the context of human serum and plasma, it's virtually certain these were human samples and not from actual rats.
• Data Provenance: The document does not specify the country of origin. The study was conducted as a comparison study between serum and heparinized plasma, supporting the market expansion. It is implied to be a prospective collection for the purpose of this comparison, although not explicitly stated as prospective or retrospective.

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

This type of submission, pertaining to a sample matrix expansion for an in vitro diagnostic (IVD) assay, does not typically involve expert review for ground truth in the way a diagnostic imaging device might. The "ground truth" for the test set is established by the measurements themselves using the existing, cleared assay on serum, and comparing those to measurements on heparinized plasma. The experts involved would be the laboratory personnel performing the assays, whose qualifications are not detailed but are assumed to be standard for a clinical laboratory.

4. Adjudication Method for the Test Set

Not applicable. This is not a study comparing human performance or interpretations, but rather an analytical comparison of an IVD assay's performance on different sample types.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is an analytical performance study comparing the assay's results across different sample matrices, not a study of human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, a "standalone" analytical performance evaluation was performed. The Stratus® CK-MB Fluorometric Enzyme Immunoassay is an automated in vitro diagnostic test. The study evaluates the performance of this assay (the "algorithm/device") directly on different sample types without human interpretive intervention beyond running the test and analyzing the numerical output.

7. The Type of Ground Truth Used

The ground truth used for this comparison study is the measurement obtained from human serum samples using the already cleared Stratus® CK-MB assay. The heparinized plasma samples are then compared against these serum measurements to demonstrate equivalence. Essentially, the "ground truth" is the established measurement performance on the original, cleared sample type.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" in the context of this submission. This is not a machine learning model, but rather an analytical device. The "training" for such a device involves its initial development and validation, which occurred prior to this 510(k) submission (for the original serum clearance).

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

Not applicable in the context of this submission. For an IVD, the initial "ground truth" during development involves rigorous analytical validation (e.g., accuracy, precision, linearity, interference, limit of detection) against reference methods or known concentrations, and then clinical correlation studies. The details of this prior validation are not part of this specific 510(k) submission which focuses on a sample type expansion.

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