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U.S. Department of Health and Human Services

Product Classification

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Device system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
Regulation Description 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.
Definition The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
Physical State in vitro diagnostic
Technical Method Nested real-time PCR. The [test] must be used in conjunction with mycobacterial culture to address the risk of false negative results and to recover the organisms for further characterization and drug susceptibility testing. The [test] should only be performed in laboratories that follow safety practices according to the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories publication (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm) and applicable state or local regulations.
Target Area Sputum
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePEU
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3373
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible