(67 days)
Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.
Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
I am sorry, but the provided text is a 510(k) summary for a medical device called "Qualicheck™4 Metabolite," which is a quality control system.
This document describes the intended use of the device (checking precision and accuracy of analyzers) and states its technological characteristics are similar to a predicate device (Qualicheck 4 Glucose). It asserts substantial equivalence based on these similarities, with the only difference being the addition of the lactate analyte.
However, the summary does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or AI-related comparative effectiveness studies. These elements are typically found in detailed study reports or clinical validation sections of a 510(k) submission, not in the summary document provided.
Therefore, I cannot fulfill your request for the tables and information related to acceptance criteria and device performance studies based on the input text.
§ 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.