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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMESOMARK
Classification Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Generic Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Applicant
Fujirebio Diagnostics, Inc.
201 great valley pkwy.
malvern, PA 19355-1307
HDE NumberH060004
Date Received09/13/2006
Decision Date01/24/2007
Product Code
OAW[ Registered Establishments with OAW ]
Docket Number 07M0038
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the mesomarktm assay. This device is indicated for: the fujirebio diagnostics, inc. (fdi) mesomarktm is an enzyme linked immunosorbent assay (elisa) for the quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. Mesomarktm values must be interpreted in conjunction with all other available clinical laboratory data.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 
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