(17 days)
LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for the Beckman-Coulter Immage™ is intended for use as an assayed quality control material for analysis.
Not Found
The provided text is an FDA 510(k) clearance letter for a quality control material, LiniCAL™ Protein 2 Calibration Verifiers. This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.
Therefore, I cannot provide the requested information based solely on the text provided. The document primarily serves as a notification of regulatory clearance.
§ 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.