(36 days)
LiniCAL™ RF-CRP Calibration Verifiers Levels A – E for Beckman Coulter Synchron CX® Systems is intended for use as an assayed quality control material for analysis.
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The provided text is a 510(k) clearance letter from the FDA for a quality control material (LiniCAL™ RF-CRP Calibration Verifiers). It does not contain information about the device's acceptance criteria, performance study details, or ground truth establishment. This type of device is a "quality control material," which is used to verify the calibration of an analytical instrument (in this case, for C-reactive protein measurement on Beckman Coulter Synchron CX® Systems). The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 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.