(129 days)
PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems.
PreciControl Bone contains lyophilized control serum based on equine serum in three concentration ranges. The controls are used for monitoring the accuracy and precision of Elecsys β-CrossLaps/serum (β-CTX), N-MID Osteocalcin, and PTH (parathyroid hormone) immunoassays.
The provided text is a 510(k) summary for the Elecsys® PreciControl Bone device, which is a quality control material for immunoassays. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.
However, the document does not contain the acceptance criteria or a study demonstrating the device meets those criteria, nor does it provide information on sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The document is a regulatory submission for a control material, which typically focuses on demonstrating equivalence to an existing product and verifying the control's stability and performance characteristics rather than clinical performance (like diagnostic accuracy) against acceptance criteria in the way an AI diagnostic device would.
Therefore, I cannot extract the requested information based on the provided text. The prompt asks for details that would typically be found in a performance study report for a diagnostic device (especially an AI-driven one), but this document is for a laboratory control material.
§ 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.