(21 days)
Abbott Immunoassay-MCC (Liquid) Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Abbott Immunoassay-MCC (Liquid) Control." This letter states that the device has been determined to be substantially equivalent to a legally marketed predicate device.
However, the document does NOT contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a new prospective clinical study with specific acceptance criteria and performance metrics. The letter confirms the device's clearance for marketing based on its intended use as an assayed quality control serum.
Therefore, I cannot extract the requested information from the provided text. To answer these questions, I would need access to the original 510(k) submission document or related study reports that would have been submitted to the FDA for review.
§ 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.