FDA 510(k)-cleared LC-MS/MS assay for tacrolimus quantification to support transplant patient care.
Tacrolimus analysis using immunoassay-based technology can suffer from cross reactivity with drug metabolites, resulting in overestimation of the parent drug. Waters MassTrak Immunosuppressants Kit (IVD), when used with Waters ACQUITY UPLC I-Class PLUS and Xevo TQD IVD Systems, delivers greater specificity for measuring tacrolimus concentrations in kidney and liver transplant patients. This leads to improved accuracy compared to immunoassays and supports individualized dosing to help manage the risks of rejection and toxicity.
Waters MassTrak Immunosuppressants Kit (IVD) | For LC-MS/MS analysis of Tacrolimus levels in patient whole blood samples to aid with Therapeutic Drug Monitoring of Tacrolimus. Image Credit: Waters Advanced Diagnostics
This comprehensive IVD kit includes all of the chemical reagents, the analytical column, and a validated method provided in the Directions for Use. No method development or validation is required when used with the Waters recommended LC-MS/MS system. The device is indicated for the quantification of the immunosuppressive drug tacrolimus (FK506; Prograf®, Astellas Europe, Munich, Germany) in whole blood samples from liver and kidney transplant patients as an aid in the management of tacrolimus therapy.
The MassTrak Immunosuppressants Kit (IVD) is 510(k)-cleared and listed with the FDA as a Class 2 device. MassTrak Immunosuppressants Kits (IVD) are available for sale and shipment exclusively in the United States.