(42 days)
LiniCAL™ Protein I Calibration Verifiers Levels A – E for Beckman Coulter Immage™ is intended for use as an assayed quality control material for analysis.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a device called "LiniCAL™ Protein I Calibration Verifiers Levels A-E for Beckman Coulter Immage™". It states that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. Such information would typically be found within the 510(k) submission itself, which is not provided here. The letter primarily confirms the FDA's decision regarding substantial equivalence for marketing purposes.
Therefore, I cannot provide the requested information based on the input text.
§ 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.