Issue Date: 10/22/2014
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
This document was developed to support the classification of 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 into class II (special controls). Nucleic acid-based in vitro diagnostic devices for the detection of MTB-complex and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens are qualitative nucleic acid-based devices that detect the presence of Mycobacterium tuberculosis complex-associated nucleic acid sequences in respiratory samples. These devices are intended to aid in the diagnosis of pulmonary tuberculosis and the selection of an initial treatment regimen when used in conjunction with clinical findings and other laboratory results. These devices do not provide confirmation of antibiotic susceptibility since other mechanisms of resistance may exist that may be associated with a lack of clinical response to treatment other than those detected by the device.
This guideline identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Firms submitting a 510(k) for a nucleic acid-based in vitro diagnostic device for the detection of MTB-complex and the genetic mutations associated with MTB-complex antibiotic resistance will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least equivalent assurance of safety and effectiveness.