(9 days)
Abbott Liquid CSF Control is intended for use as a quality control to monitor the Abbott Eiquid OCF Ochiretto procedures for the analytes listed in the value sheet.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Abbott Liquid CSF Control" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
This type of FDA letter is an administrative confirmation of substantial equivalence based on information submitted by the manufacturer in their 510(k) notification. It summarizes the regulatory determination, but it does not detail the technical performance data or specific study design elements that would have been part of the manufacturer's submission.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the actual 510(k) submission document itself, which would contain the performance data and study details.
§ 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.