(4 days)
Elecsys ® PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®) and Myoglobin immunoassays using the Elecsys immunoassay systems.
Boehringer Mannheim Elecsys ® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB (human), Troponin T (human recombinant) and Myoglobin (human) for monitoring the accuracy and precision of Elecsys CK-MB, Troponin T and Myoglobin immunoassays.
I am sorry, but the provided text is a 510(k) summary for a quality control device (Boehringer Mannheim Elecsys ® PreciControl Cardiac), not a medical device that performs a diagnostic function.
Therefore, the concepts of "acceptance criteria," "device performance," "study," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth type," "training set sample size," and "how ground truth for training set was established" are not applicable in the context of this document.
This document describes a control material used to monitor the accuracy and precision of immunoassay systems, not a device that generates diagnostic results itself.
§ 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.