Product Classification

• Device: immunoassay, anti-seizure drug
• Regulation Description: Diphenylhydantoin test system.
• Definition: To aid in management of patients treated with anti-seizure drug.
• Physical State: liquid reagents
• Technical Method: Immunoassay intented for use on clinical chemistry analyzers
• Target Area: in vitro diagnostic
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: NWM
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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

Guidance Document

• Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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