Product Classification

• Device: test, methadone, over the counter
• Regulation Description: Methadone test system.
• Definition: The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
• Physical State: In vitro diagnostic device
• Technical Method: Immunoassay
• Target Area: Urine
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: PTG
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• 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