(33 days)
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.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.