(4 days)
Architect Total T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect Total T4 MasterCheck Level 0 contains human serum Architect Total T4 MasterCheck Levels 1, 2 and 3 contain T4 prepared in human serum. Preservative: Sodium Azide.
This document is a 510(k) summary for the Bio-Rad Architect Total T4 MasterCheck, a device intended for verifying sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. It claims substantial equivalence to the Casco Standards Document Serum Multi-Analyte Verification Test Set. However, the provided text does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for device performance evaluation.
Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study that proves the device meets them based only on the provided input. The document is primarily focused on describing the device, its intended use, and its substantial equivalence to a predicate device for regulatory purposes.
§ 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.