(22 days)
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine based quality control material for use as a consistent test sample of Known Concentrations that is assayed along with patient serum specimens when assaying for any of the listed analytes. The material is used in various general chemistry and immunologically related assays to document analytical precision, as well as reagent and instrument performance.
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine based quality control material for use as a consistent test sample of Known Concentrations that is assayed along with patient serum specimens when assaying for any of the listed analytes.
The provided text is a 510(k) clearance letter from the FDA for a chemistry and TDM control device. It pertains to a laboratory quality control product, not an AI/ML powered medical device or a diagnostic device that performs analysis on patient samples.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment for an AI/ML powered medical device. The letter confirms substantial equivalence to a predicate device for a quality control material used in laboratory assays.
§ 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.