(58 days)
The use of control material to estimate test precision in a test system and to detect systematic deviation that may arise from reagent or analytical instrument variation in the measurement of cyclosporine A, tacrolimus and rapamycin.
Not Found
This document is a 510(k) clearance letter from the FDA for a quality control material called "Rap/Tac/CsA Control." It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a control material for estimating test precision and detecting systematic deviation in a test system, not a diagnostic device itself.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls. The "Indications for Use" section further clarifies its purpose as a quality 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.