(79 days)
The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose. The solutions are intended for in-vitro use only.
Supreme II Control Solutions
The provided text is a 510(k) clearance letter from the FDA for a device called "Supreme II Control Solutions." This letter indicates that the device has been cleared for market based on its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter is a regulatory document, not a scientific study report.
§ 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.