Product Classification

• Device: potassium dichromate specific reagent for alcohol
• Regulation Description: Alcohol test system.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: DMI
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3040
• 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

Recognized Consensus Standard

• 7-48 CLSI C60-A
  Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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