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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
PMA NumberP010033
Supplement NumberS006
Date Received12/04/2003
Decision Date12/02/2004
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of synthetic peptide antigens esat-6 and cfp-10 and removal of the tuberculin ppd and m. Avium ppd antigens used in the quantiferon - tb. The device, as modified, will be marketed under the trade name quantiferon - tb gold and is indicated for use as an in vitro diagnostic test using peptide cocktails simulating esat-6 and cfp-10 proteins to stimulate cells in heparinized whole blood. Detection of interferon-y by elisa is used to identify in vitro responses to esat-6 and cfp-10 that are associated with mycobacterium tuberculosis infection. The device approval is for use of an 8-point calibration curve with manual calculations.