Drug Metabolizing Enzyme Genotyping Systems

NTI · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3360

Classification

FDA Product Code: NTI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3360
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 11
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown