|Trade Name||IMX TACROLIMUS II|
|Classification Name||enzyme immunoassay, tracrolimus|
|Generic Name||enzyme immunoassay, tracrolimus|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the current labeling for the device per 21 cfr 814. 39(d)(2). The current package insert states "hematocrit values ranging from 25 to 45% resulted in less than 12% error in detecting tacrolimus. " the package insert will be modified to state "hematocrit interference was evaluated by spiking known amounts of tacrolimus into pooled, whold blood samples diluted with saline. Hematocrit values ranging from 25 to 45% resulted in less than 31% error in detecting tacrolimus.