Product Classification

• Device: drug metabolizing enzyme genotyping systems
• Regulation Description: Drug metabolizing enzyme genotyping system.
• Definition: Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: NTI
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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

Recognized Consensus Standard

• 7-237 CLSI MM01-A3 (Replaces MM01-A2)
  Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition

Guidance Document

• Drug Metabolizing Enzyme Genotyping System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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