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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS008
Date Received09/04/1998
Decision Date09/30/1999
Reclassified Date 06/23/2014
Docket Number 00M-0578
Notice Date 02/15/2000
Advisory Committee Microbiology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
This device, a target-amplified nucleic acid probe test, is indicated for: the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA in acid-fast bacilli (AFB) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e.g., bronchalveolar lavages or bronchial aspirates) or tracheal aspirates. The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis. MTD is to be used as an adjunctive test for evaluating either AFB smear positive or negative sediments prepared using NALC-NaOH digestion-decontamination of respiratory specimens. Patients who are suspected of having pulmonary TB based on clinical evaluation and who have received no antituberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test. The MTD test should be performed only in laboratories proficient in the culture and identification of M.tuberculosis (Level II and III or extent 3 and 4). The MTD test must be performed in conjunction with mycobacterial culture.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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