Product Classification

• Device: mycophenolic acid test system
• Regulation Description: Sirolimus test system.
• Definition: An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
• Physical State: Liquid
• Technical Method: Enzyme-mimicking assay with MPA concentration inversely proportional to the formation of NADH.
• Target Area: Renal and Cardiac Transplant Patients
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: OAV
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3840
• Device Class: 2
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc