|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.|
|Trade Name||QUANTIFERON -TB GOLD|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| 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.