(41 days)
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.
Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum. Preservative: Antimicrobial Agent.
The provided text is a 510(k) summary for the Bio-Rad Laboratories' Architect Progesterone MasterCheck. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes the intended use and technological characteristics of the device but does not contain information on acceptance criteria for a study proving device performance, nor details of a study with sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence based on the device's intended use, form, matrix, storage, analytes, and open vial claim, comparing these characteristics to a predicate device. It also includes the FDA's response letter indicating that the device has been found substantially equivalent.
Therefore, I cannot provide the requested information from the given text. The document does not describe a performance study with detailed acceptance criteria and results.
§ 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.