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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIMX TACROLIMUS II
Generic NameENZYME IMMUNOASSAY, TRACROLIMUS
Regulation Number862.1678
ApplicantAbbott Laboratories
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064
PMA NumberP970007
Supplement NumberS002
Date Received02/27/2001
Decision Date03/30/2001
Reclassified Date 10/16/2002
Product Code MLM 
Advisory Committee Toxicology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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