(15 days)
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.
The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma.
This document describes the analytical studies performed for the Beckman Coulter Access CK-MB assay. The studies focus on demonstrating the performance of the device rather than comparing it to human readers or establishing ground truth from expert consensus or pathology, as typically seen in AI-based diagnostic device submissions.
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1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each metric. Instead, it presents the results of analytical studies to demonstrate the device's performance characteristics. This is common for in-vitro diagnostic devices where the "acceptance" is often implied by meeting established scientific and regulatory standards for assay performance.
| Performance Metric | Reported Device Performance |
|---|---|
| Within-run Imprecision | 1.15%CV to 2.32%CV |
| Between-run Imprecision | 1.47%CV to 2.89%CV |
| Total Imprecision | 2.66%CV to 3.54%CV |
| Analytical Sensitivity (LoD) |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.