(10 days)
The MAS® Lipid control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS® Lipid control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
The provided text is an FDA 510(k) clearance letter for a device named "MAS® Lipid Control." This document is a regulatory communication and does not contain the acceptance criteria, study details, or performance data requested in the prompt.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls.
Therefore, I cannot provide accurate answers to the questions based on the given input text. The information requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in the 510(k) submission itself, not in the clearance letter.
§ 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.