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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 MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS007
Date Received08/17/1998
Decision Date09/02/1999
Reclassified Date 06/23/2014
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.
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