Product Classification

• Device: lipoprotein, high density, hdl, over the counter
• Regulation Description: Cholesterol (total) test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: NAQ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1175
• Device Class: 1
• 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

• 7-88 CLSI C37-A
  Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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