Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 4RZ
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:  S005 S006 S002 S003 S004 S001 S007 S008 S009 S011 S014 
S016 S019 S027 S023 S015 S013 S012 S018 S021 S017 S025 S026 
S028 S022 S024 S020 
-
-