(79 days)
The Elecsys® SHBG CalCheck is intended for use in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.
The provided text describes a medical device called "Elecsys® SHBG CalCheck," a calibration verification material. However, the document does not contain specific acceptance criteria or a detailed study demonstrating how the device meets such criteria.
The text focuses on the 510(k) submission process, stating the device's intended use, its substantial equivalence to a predicate device, and the regulatory approval. It mentions that "Performance Characteristics" were evaluated for "value assignment and stability," but it does not provide the results of these evaluations or any numerical acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.
The provided text primarily serves as a regulatory approval document (510(k) summary and FDA clearance letter) and does not detail the technical performance study 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.