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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
19300 germantown road
germantown, MD 20874
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.