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The MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

The MMB Calibrator is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable CKMB. Levels 2 through 5 contain human CKMB. The kit consists of ten vials; two at each of five levels.

The provided text is a summary of safety and effectiveness information for the MMB Calibrator, a medical device used to calibrate a clinical chemistry system for CKMB (Creatine Kinase-MB) testing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a diagnostic performance. Therefore, I cannot provide the requested information.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number of experts, or adjudication methods for a test set.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established.

The document primarily describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence based on similar characteristics like intended use, analytes, and general nature as a calibrator.

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