A tacrolimus test measures the amount of tacrolimus in a patient’s blood. Tacrolimus is an immunosuppressant drug that prevents organ rejection after transplantation

Intended Use of Tacrolimus Test System

A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

Intended Use:

It is used for quantitative determination of the tacrolimus concentration in human whole blood. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.

Device Description

Enzyme Immunoassay (EIA) is a method used to detect or quantify substances in biological samples, including drugs like Tacrolimus. Tacrolimus, an immunosuppressive drug used to prevent organ rejection after transplants, can be measured using EIA. The process involves preparing a blood or plasma sample, binding it to an antibody specific to Tacrolimus, and using an enzyme-linked antibody to produce a detectable signal, such as a color change. This signal is proportional to the amount of Tacrolimus in the sample, allowing for accurate measurement of drug levels. Monitoring Tacrolimus concentrations is essential to ensure they stay within a therapeutic range, preventing rejection or toxicity.

• Precision,
• linearity,
• detection limits
• analytical specificity

Clinical Testing

No Guidance available for 510k submission