PMA P970007S002

Device: IMX TACROLIMUS II
Applicant: Abbott Laboratories
PMA number: P970007
Supplement: S002
Product code: MLM
Decision date: 2001-03-30
Classification: Clinical Toxicology
Generic name: ENZYME IMMUNOASSAY, TRACROLIMUS
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.

Current openFDA PMA Record#

Device: IMX TACROLIMUS II
Applicant: Abbott Laboratories
PMA number: P970007
Supplement: S002
Product code: MLM
Generic name: ENZYME IMMUNOASSAY, TRACROLIMUS
Decision date: 2001-03-30
Decision code: APPR
Date received: 2001-02-27
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.