Issue Date: September 30, 2004
Issued by: Office of Medical Products and Tobacco, Center for Devices and Radiological Health
This guidance was developed as a special controls guidance to support the classification of sirolimus (rapamycin) test systems into class II. Sirolimus test systems are intended to quantitatively determine sirolimus concentrations in whole blood as an aid in the management of transplant patients receiving therapy with sirolimus. Many aspects of this document, especially those concerning performance characteristics and risks to health, were developed using information FDA obtained from the Therapeutic Drug Management (TDM) Roundtable. This working group was composed of representatives from laboratory medicine as well as device manufacturers.
This guidance document addresses instrument-based chromatographic assays or immunoassays used in central clinical laboratories. It does not address assays that use other methodologies or point of care assays.