Product Classification

• Device: low-density lipoprotein (ldl) cholesterol sub-fraction test
• Regulation Description: Lipoprotein test system.
• Definition: For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
• Physical State: The assay uses surfactants and enzymes that react with certain groups of lipoproteins.
• Technical Method: Quantitative colorimetric assay
• Target Area: Human serum or plasma.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: PYP
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1475
• Device Class: 1
• 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

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