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
• Submission Type: 510(k)
• Regulation Number: 862.3360
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI MM01-A3 Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
• CLSI MM9-A Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine

Guidance Document

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

Third Party Review

Not Third Party Eligible