NTI — Drug Metabolizing Enzyme Genotyping Systems Class II
FDA product code NTI covers "Drug Metabolizing Enzyme Genotyping Systems", a Class II medical device regulated under 21 CFR 862.3360. Submissions are reviewed by the Clinical Toxicology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTI
- Device Class
- Class II
- Regulation Number
- 862.3360
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220026 | genomadix | Genomadix Cube CYP2C19 System | March 21, 2023 |
| K170492 | luminex molecular diagnostics | xTAG CYP2D6 Kit v3 | August 11, 2017 |
| K131565 | luminex molecular diagnostics | XTAG CYP2C19 KIT V3 | September 11, 2013 |
| K123891 | spartan bioscience | SPARTAN RX CYP2C19 TEST SYSTEM | August 12, 2013 |
| K130189 | luminex molecular diagnostics | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | May 21, 2013 |
| K120466 | nanosphere | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | November 6, 2012 |
| K101683 | autogenomics, incorporated | INFINITI CYP2C19 ASSAY | October 25, 2010 |
| K093420 | luminex molecular diagnostics | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0 | August 26, 2010 |
| K051824 | third wave technologies | INVADER UGT1A1 MOLECULAR ASSAY | August 18, 2005 |
| K043576 | roche molecular systems | ROCHE AMPLICHIP CYP450 TEST | January 10, 2005 |
| DEN040011 | roche molecular systems | AMPLICHIP CYP450 TEST, MODEL 04381866190 | December 23, 2004 |