Product Classification

• Device: cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
• Definition: A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.
• Physical State: Assay kit including capturing and detecting antibody, buffers, controls and calibrators.
• Technical Method: Enzyme-linked Immunosorbent Assay (ELISA)
• Target Area: In vitro diagnostic test usinh human serum.
• Review Panel: Immunology
• Product Code: OAW
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: HDE - Humanitarian Device Exemption
• Device Class: HDE
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible