NTI
11 FDA 510(k) clearances · Product code
132 daysmedian time to decision
296 days90th percentile
11clearances measured
FDA profile
- Official device name
- Drug Metabolizing Enzyme Genotyping Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3360
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Genomadix Cube CYP2C19 System (K220026) | Genomadix, Inc. | 2023-03-21 |
| xTAG CYP2D6 Kit v3 (K170492) | Luminex Molecular Diagnostics, Inc. | 2017-08-11 |
| XTAG CYP2C19 KIT V3 (K131565) | Luminex Molecular Diagnostics, Inc. | 2013-09-11 |
| SPARTAN RX CYP2C19 TEST SYSTEM (K123891) | Spartan Bioscience, Inc. | 2013-08-12 |
| XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (K130189) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 |
| VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (K120466) | Nanosphere, Inc. | 2012-11-06 |
| INFINITI CYP2C19 ASSAY (K101683) | Autogenomics, Incorporated | 2010-10-25 |
| XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) (K093420) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 |
| INVADER UGT1A1 MOLECULAR ASSAY (K051824) | Third Wave Technologies, Inc. | 2005-08-18 |
| ROCHE AMPLICHIP CYP450 TEST (K043576) | Roche Molecular Systems, Inc. | 2005-01-10 |
| AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011) | Roche Molecular Systems, Inc. | 2004-12-23 |
Track NTI automatically
Every clearance here is in the API, with alerts when new ones post.