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U.S. Department of Health and Human Services

Medical Devices

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CEDIA® Sirolimus Assay - K034069

This is a brief overview of information related to FDA’s clearance to market this product. 


Product Name: CEDIA® Sirolimus Assay
Manufacturer: Microgenics Corporation
Address: 46360 Fremont Blvd., Fremont CA 94538
Clearance Date: July 28, 2004

What is it? The CEDIA® Sirolimus Assay is a lab test that can be used to measure concentration of the drug, sirolimus, in whole blood. This test is used as an aid in the treatment of kidney transplant patients taking sirolimus. This is the first FDA cleared sirolimus assay using immunoassay technology that can be used in most central laboratories. Until now, sirolimus tests were performed only by specialized reference laboratories.
How does it work? The assay detects sirolimus by using a protein (specifically, an antibody) that binds to the drug.

When is it used? The assay can be used for kidney transplant patients who are taking sirolimus, at any time when estimating the blood level of sirolimus might help manage treatment.

What will it accomplish? The assay is used together with other lab tests and patient evaluations to help determine if a patient is receiving an appropriate amount of sirolimus.

When should it not be used? The assay should not be used alone to make treatment decisions. It should be used along with clinical evaluation and other lab tests.

This kind of assay (i.e., immunoassay) detects the drug, sirolimus, as well as some breakdown products (metabolites) of the drug. This kind of assay cannot always differentiate between the drug sirolimus and its breakdown products. In situations where it is important to measure sirolimus more specifically, use of more specific assays (e.g. chromatography assays) may be appropriate. To best interpret sirolimus test results, physicians should be aware of which specific test was used.

Additional information: 
FDA Substantial Equivalence letter is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k034069.pdf