(130 days)
The Elecsys CK-MB CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Not Found
This document is a marketing clearance letter from the FDA for a medical device called "Elecsys CK-MB CalCheck 5." It does not contain information about acceptance criteria or a study proving device performance in the way requested. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.