Product Classification

• Device: kit, test, pregnancy, hcg, over the counter
• Regulation Description: Human chorionic gonadotropin (HCG) test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: LCX
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1155
• 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

• Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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