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IMMULITE CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in heparinized plasma or serum. It is intended strictly for in vitro use as an aid in patient and the assessment of prognosis of myocardial infarction.

IMMULITE® CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer.

IMMULITE® CK-MB is a chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

The patient sample, a ligand-labeled anti-CK-MB monoclonal antibody and an alkaline phosphatase-labeled anti-CK-BB polyclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, CK-MB in the sample forms an antibody sandwich complex which, in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash: substrate is then added and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® CK-MB device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of a specific accuracy, sensitivity, or specificity threshold. Instead, the performance is demonstrated through a method comparison study. The implicit acceptance criterion is "substantial equivalence" to the predicate device, Roche® Isomune® -CK. This is demonstrated by the linear regression analysis results.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: Forty-three (43) patient samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient samples," implying they were obtained clinically.
• Retrospective or Prospective: Not explicitly stated, but the description "patient samples" (past tense) and the comparison to an already marketed device suggest a retrospective analysis of collected clinical samples.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This diagnostic device determines a quantitative analyte concentration. The "ground truth" for the test set is established by the predicate device, the Roche® Isomune® -CK.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As noted above, the "ground truth" for the comparison is the measurement obtained from the predicate device, not human expert consensus.

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

• MRMC Study: No, an MRMC study was not done. This is a quantitative in vitro diagnostic device, not an imaging or qualitative diagnostic device that would typically involve human readers interpreting results.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was implicitly done to characterize the device's measurements relative to a known standard (the predicate device). The stated "performance equivalence" and "method comparison" sections detail this. The IMMULITE® CK-MB's measurements are compared directly to those of the predicate device at various concentrations.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the comparative study was the results obtained from the predicate device, Roche® Isomune® -CK. This is a common approach for demonstrating substantial equivalence for new diagnostic assays.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided text. The document describes a comparison study for performance evaluation, not a description of the device's internal algorithm development or training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified. This information would typically be part of a detailed assay development report, which is not included in this 510(k) summary. Given it's an immunometric assay, the "training" (calibration) would typically involve known standards with defined CK-MB concentrations.

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