Product Classification

• Device: radioimmunoassay, tricyclic antidepressant drugs
• Regulation Description: Tricyclic antidepressant drugs test system.
• Definition: Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
• Physical State: The device may be composed of a collection apparatus and / or measurement assay.
• Technical Method: Serum or urine are collected and analyzed for the presence of antidepressant drugs.
• Target Area: Serum or urine.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: LFG
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3910
• 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

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc