Device Dossier

Immunosuppressant therapeutic drug monitoring IVDs

Device Dossier for Immunosuppressant therapeutic drug monitoring IVDs (CT866 - Immunosuppressant therapeutic drug monitoring IVDs, Class 3, sponsor…

Intended purpose

The calibrators are intended to be used in clinical laboratories by trained professionals to accurately and precisely quantitate drug levels of cyclosporine, sirolimus, tacrolimus and everolimus in human whole blood samples as an aid in the management of immunosuppressive drug therapy. The calibrators are used to establish a calibration curve which is used to interpolate the immunosuppressant concentrations using liquid chromatography – tandem mass spectrometry (LC-MS/MS) systems.

TGA Public Summary