Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Sirolimus Test System Devices

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The Food and Drug Administration (FDA) is classifying the sirolimus test system device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Sirolimus Test Systems." The device is intended to measure sirolimus levels in whole blood as an aid to managing therapy for transplant patients receiving sirolimus, an immunosuppressive drug. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.