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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.
 
DeviceT-SPOT TB TEST
Generic NameMycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
ApplicantOXFORD IMMUNOTEC,LTD.
94C INNOVATION DRIVE
MILTON PARK, ABINGDON OXFORDSHIRE OX14
PMA NumberP070006
Supplement NumberS001
Date Received02/27/2009
Decision Date07/09/2010
Product Code OJN 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF T-CELL XTEND REAGENT WITH THE T-SPOT.TB TEST, IN ORDER TO EXTEND THE TIME FROM SAMPLE COLLECTION TO SAMPLE PROCESSING FROM WITHIN 8 HOURS OF VENIPUNCTURE TO BETWEEN 23 AND 30 HOURS POST VENIPUNCTURE; AND TO MAKE A TECHNICAL CORRECTION TO THE T-SPOT.TB TEST PACKAGE INSERT TO CHANGE THE NUMBER OF BLOOD COLLECTION TUBES REQUIRED FROM (2) 6 ML HEPARIN TUBES TO (1) 6 ML HEPARIN TUBE. THE T-CELL XTEND REAGENT IS INDICATED FOR USE WITH THE T-SPOT.TB TEST FOR THE PRE-TREATMENT OF WHOLE BLOOD PRIOR TO LYMPHOCYTE SEPARATION . THE REAGENT AIDS IN THE REMOVAL OF SELECTED WHITE BLOOD CELLS FROM WHOLE BLOOD STORED AT ROOM TEMPERATURE (18-25 DEGREES C).
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