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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.
 
DeviceQUANTIFERON TB GOLD IN TUBE
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQiagen
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS011
Date Received06/01/2006
Decision Date10/10/2007
Product Code NCD 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES. DETECTION OF INTERFERON-Y BY ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) IS USED TO IDENTIFY IN VITRO RESPONSES TO THESE PEPTIDE ANTIGENS THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.
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