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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceT SPOT-TB TEST
Generic NameMycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
ApplicantOxford Immunotec, Ltd.
94c Innovation Dr.
Milton Park, Abingdon Oxfordshire OX14
PMA NumberP070006
Date Received02/06/2007
Decision Date07/30/2008
Product Code OJN 
Docket Number 08M-0477
Notice Date 08/26/2008
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE T-SPOT-TB. THIS DEVICE IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF EFFECTOR T CELLS THAT RESPOND TO STIMULATION BY MYCOBACTERIUM TUBERCULOSIS ANTIGENS ESAT-6 AND CFP-10 BY CAPTURING INTERFERON GAMMA (IFN-¿) IN THE VICINITY OF T CELLS IN HUMAN WHOLE BLOOD COLLECTED IN SODIUM CITRATE OR SODIUM OR LITHIUM HEPARIN. IT IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF M. TUBERCULOSIS INFECTION. T-SPOT-TB IS AN INDIRECT TEST FOR M. TUBERCULOSIS INFECTION (INCLUDING DISEASE) AND IS INTENDED FOR USE IN CONJUNCTION WITH RISK ASSESSMENT, RADIOGRAPHY AND OTHER MEDICAL AND DIAGNOSTIC EVALUATIONS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 
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