(28 days)
LiniCAL™ hsCRP Calibration Verifiers Levels A - E are intended for use as an assayed quality control material to verify calibration and/or assess linearity of the Beckman-Coulter Immage TM
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I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria, device performance tables, study details (sample sizes, data provenance, ground truth, adjudication methods, MRMC studies), or training set information. The document is a 510(k) clearance letter for a medical device (LiniCAL™ hsCRP Calibration Verifiers) and primarily concerns regulatory approval.
§ 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.