21 CFR 862.3360 — Drug Metabolizing Enzyme Genotyping Systems
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3360
Identification
A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 2 | 11 | 3rd Party |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | 2 | 6 | 3rd Party |
Special Controls
NTI — Drug Metabolizing Enzyme Genotyping Systems
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.
eCFR
NTI — Drug Metabolizing Enzyme Genotyping Systems
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.
Ecfr Llm
ODW — Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.
eCFR
