Performance Characteristics for an Immunoassay

Abstract

In the United States of America the medical device amendments of 1976 established a comprehensive system for regulation of medicaldevices intended for human use. One provision of the amendmentsestablishes three categories (classes) of devices depending onthe regulatory controls needed to provide reasonable assurance ofsafety and effectiveness. The categories are as follows: Class I, General Controls; Class II, Performance Standards; and Class III, Premarket Approval. The performance characteristics of an immunology device that requires premarket approval (CLASS III) may be viewed as an extension of successfully completed scientific and laboratory investigations. Clinical trials of the device establish analyte levels in well-defined populations of healthy and diseased individuals and provide an estimate of the central tendency of analyte range. The performance characteristics of an immunoassay kit are established by laboratory studies, these studies include but are not limited to the following studies: reproducibility, recovery, linearity, stability, specificity, and sensitivity.