Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

The Food and Drug Administration (FDA) is proposing to reclassify 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). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

Agency Contact: Janice A. Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002, 301-796-6207.