Product Classification

• Device: cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
• Regulation Description: Drug metabolizing enzyme genotyping system.
• Definition: An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
• Physical State: genotyping test system
• Technical Method: Uses DNA genotyping technology to determine patient genotype at the Cytochrome P450 2C9 (CYP450 2C9) locus.
• Target Area: clinical samples (blood, saliva, buccal swab samples)
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: ODW
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.3360
• 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

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