title: Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.
abstract: The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D024881:Drug Resistance, Bacterial / Q000235:genetics*; D006801:Humans; D008829:Microbiology / Q000145:classification / Q000295:instrumentation*; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000235:genetics*; D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014376:Tuberculosis / Q000175:diagnosis* / Q000235:genetics; D014481:United States
chemical_list: D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic