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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
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009