Product Classification

• Device: gabapentin assay
• Regulation Description: Diphenylhydantoin test system.
• Definition: Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
• Physical State: Liquid reagents
• Technical Method: Quantitative, Homogenous Enzyme Immunoassay
• Target Area: in vitro diagnostic
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: OTF
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3350
• 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