title: Microbiology devices; reclassification of nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens. Final rule.
abstract: The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ''Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
mesh_terms: D001992:Bronchoalveolar Lavage Fluid / Q000382:microbiology; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009169:Mycobacterium tuberculosis; D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D012137:Respiratory System / Q000382:microbiology; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009696:Nucleic Acids; D011933:Reagent Kits, Diagnostic