title: Performance characteristics for an immunoassay.
abstract: In the United States of American 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 on the regulatory controls needed to provide reasonable assurance of safety 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.
authors.affiliation: Division of Clinical Laboratory Devices, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850.
authors.forename: S K
authors.initials: SK
authors.lastname: Vadlamudi
authors.forename: W D
authors.initials: WD
authors.lastname: Stewart
authors.forename: K J
authors.initials: KJ
authors.lastname: Fugate
authors.forename: T M
authors.initials: TM
authors.lastname: Tsakeris
mesh_terms: D000906:Antibodies; D000951:Antigens, Neoplasm / Q000032:analysis; D014408:Biomarkers, Tumor / Q000032:analysis; D006801:Humans; D007118:Immunoassay / Q000592:standards* / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000906:Antibodies; D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor