NTI · Drug Metabolizing Enzyme Genotyping Systems
Clinical Toxicology · 21 CFR 862.3360 · Class 2
Overview
| Product Code | NTI |
|---|---|
| Device Name | Drug Metabolizing Enzyme Genotyping Systems |
| Regulation | 21 CFR 862.3360 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Special Controls
The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | Mar 21, 2023 | SESE |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | Aug 11, 2017 | SESE |
| K131565 | XTAG CYP2C19 KIT V3 | Luminex Molecular Diagnostics, Inc. | Sep 11, 2013 | SESE |
| K123891 | SPARTAN RX CYP2C19 TEST SYSTEM | Spartan Bioscience, Inc. | Aug 12, 2013 | SESE |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | Luminex Molecular Diagnostics, Inc. | May 21, 2013 | SESE |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | Nanosphere, Inc. | Nov 6, 2012 | SESE |
| K101683 | INFINITI CYP2C19 ASSAY | Autogenomics, Incorporated | Oct 25, 2010 | SESE |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) | Luminex Molecular Diagnostics, Inc. | Aug 26, 2010 | SESE |
| K051824 | INVADER UGT1A1 MOLECULAR ASSAY | Third Wave Technologies, Inc. | Aug 18, 2005 | SESE |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | Roche Molecular Systems, Inc. | Jan 10, 2005 | SESE |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | Roche Molecular Systems, Inc. | Dec 23, 2004 | DENG |
Top Applicants
- Luminex Molecular Diagnostics, Inc. — 4 clearances
- Roche Molecular Systems, Inc. — 2 clearances
- Autogenomics, Incorporated — 1 clearance
- Genomadix, Inc. — 1 clearance
- Nanosphere, Inc. — 1 clearance
