(47 days)
VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.
liquid unassayed human serum based quality control material
This document is a 510(k) clearance letter from the FDA for a device called "Virotrol III". It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, or MRMC results) from the provided 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.