Product Classification

• Device: vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
• Definition: An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
• Physical State: genotyping test system
• Technical Method: Uses DNA genotyping technology to determine patient genotype at the Vitamin k epoxide reductase complex subunit one (VKORC1) gene locus.
• Target Area: clinical samples (blood, saliva, buccal swab samples)
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: ODV
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.7750
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• global quality and regulatory services
• regulatory technology services, llc
• sgs north america