• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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 Nameenzyme immunoassay, tracrolimus
Generic Nameenzyme immunoassay, tracrolimus
Regulation Number862.1678
Abbott Laboratories
200 abbott park rd.
abbott park, IL 60064
PMA NumberP970007
Supplement NumberS002
Date Received02/27/2001
Decision Date03/30/2001
Product Code
MLM[ Registered Establishments with MLM ]
Advisory Committee Toxicology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product 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.