Search Results

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.

Here's a breakdown of the requested information based on the provided text:

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.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size:
  • Method Comparison: 120 samples.
  • Imprecision: Not explicitly stated as a single number for a "test set." Imprecision studies usually involve multiple replicates across different runs/days. The levels tested ranged from 4.5 to 172.3 ng/mL.
  • Dilution Recovery: Not explicitly stated as a single number, but involved "lithium heparin plasma samples."
  • Analytical Specificity: Not explicitly stated.
  • Reference Intervals: Not explicitly stated.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective for the method comparison (comparing existing samples) and prospective for the analytical performance studies (performed by the manufacturer).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is an in-vitro diagnostic assay for quantitative measurement of a biomarker. The "ground truth" is typically established by meticulously prepared analytical samples (dilutions, spiked samples, known concentrations) or by comparing the device's measurements to a recognized gold standard method (the predicate device in this case). It does not involve human expert interpretation of images or clinical cases to establish a diagnostic ground truth.

4. Adjudication Method for Test Set

• Not Applicable. As this is an assay for quantitative measurement, there is no adjudication process involving human review of results in the traditional sense, as would be expected for a diagnostic imaging or clinical decision-support AI.

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

• No. This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for measuring a biomarker. MRMC studies are typically conducted for diagnostic imaging devices or AI systems that assist human readers in interpreting complex data. The performance of this device is assessed by its analytical characteristics (precision, accuracy, linearity, etc.) rather than its impact on human reader performance.

6. Standalone (Algorithm Only) Performance

• Yes. The described studies are all of the standalone performance of the assay system (reagents and analyzer) without human-in-the-loop performance being a primary metric. The analytical results (imprecision, sensitivity, linearity, method comparison) directly represent the algorithm's (assay's) performance.

7. Type of Ground Truth Used

• Analytical Standards and Predicate Device Comparison:
  • For metrics like imprecision, analytical sensitivity, and dilution recovery, the ground truth is based on known concentrations in controls, calibrators, or prepared samples.
  • For method comparison, the "ground truth" is the results obtained from the legally marketed predicate device (Access® CK-MB Assay for Use on the Access® Immunoassay Analyzer, K000716). The comparison aims to show substantial equivalence.

8. Sample Size for Training Set

• Not Stated/Not Applicable in the traditional sense. This is not a machine learning or AI device that undergoes a discrete "training" phase with a dataset, as typically understood in the context of deep learning. Instead, the device's "training" and optimization would involve extensive R&D, formulation development, and internal testing during its development phase, which is not typically detailed in 510(k) summaries as a "training set" with specific sample numbers.

9. How Ground Truth for Training Set Was Established

• Not Applicable. See point 8. The "ground truth" during the development of such an assay would be established through a rigorous process of chemical and biological validation using highly characterized reference materials and established analytical methods to ensure the assay correctly measures CK-MB.

Ask a specific question about this device