ODW · Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Clinical Toxicology · 21 CFR 862.3360 · Class 2
Overview
| Product Code | ODW |
|---|---|
| Device Name | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | May 24, 2019 | SESE |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | May 26, 2016 | SESE |
| K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT | Trimgen Corporation | Feb 6, 2009 | SESE |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Osmetech Molecular Diagnostics | Jul 17, 2008 | SESE |
| K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | Autogenomics, Incorporated | Jan 23, 2008 | SESE |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | Nanosphere, Inc. | Sep 17, 2007 | SESE |
Top Applicants
- Akonni Biosystems, Inc. — 1 clearance
- Autogenomics, Incorporated — 1 clearance
- Genmark Diagnostics, Incorporated — 1 clearance
- Nanosphere, Inc. — 1 clearance
- Osmetech Molecular Diagnostics — 1 clearance
