Product Classification

• Device: enzyme immunoassay, oxcarbazepine metabolite
• Regulation Description: Neuroleptic drugs radioreceptor assay test system.
• Definition: An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
• Physical State: In vitro reagents
• Technical Method: Enzyme immunoassay
• Target Area: For in vitro diagnostic use only
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: POX
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3645
• 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

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