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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namemycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
Generic Namemycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
94c innovation drive
milton park, abingdon oxfordshire OX14
PMA NumberP070006
Date Received02/06/2007
Decision Date07/30/2008
Product Code
OJN[ Registered Establishments with OJN ]
Docket Number 08M-0477
Notice Date 08/26/2008
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009