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U.S. Department of Health and Human Services

Product Classification

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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 CodeNTI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
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
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