Drug Metabolizing Enzyme Genotyping Systems
FDA product code NTI · Class II (moderate risk) · 21 CFR 862.3360 · Clinical Toxicology
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.
10510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 SystemNTI · Abbreviated | Genomadix, Inc. | 03/21/2023SE |
| K170492 | xTAG CYP2D6 Kit v3NTI · Special | Luminex Molecular Diagnostics, Inc. | 08/11/2017SE |
| K131565 | Xtag CYP2C19 Kit V3NTI · Traditional | Luminex Molecular Diagnostics, Inc. | 09/11/2013SE |
| K123891 | Spartan RX CYP2C19 Test SystemNTI · Abbreviated | Spartan Bioscience, Inc. | 08/12/2013SE |
| K130189 | Xtag CYP2D6 Kit V3 (Including Tdas CYP2D6 Software)NTI · Traditional | Luminex Molecular Diagnostics, Inc. | 05/21/2013SE |
| K120466 | Verigene CYP2C19 Nucleic Acid Tes (2C19)NTI · Traditional | Nanosphere, Inc. | 11/06/2012SE |
| K101683 | Infiniti CYP2C19 AssayNTI · Abbreviated | Autogenomics, Incorporated | 10/25/2010SE |
| K093420 | Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)NTI · Traditional | Luminex Molecular Diagnostics, Inc. | 08/26/2010SE |
| K051824 | Invader UGT1A1 Molecular AssayNTI · Traditional | Third Wave Technologies, Inc. | 08/18/2005SE |
| K043576 | Roche Amplichip CYP450 TestNTI · Traditional | Roche Molecular Systems, Inc. | 01/10/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2559-2014 Class III | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20…Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing… | Nanosphere, Inc. | 03/18/2014Terminated |
| Z-3112-2011 | xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular…Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on… | Luminex Corporation | 05/24/2011Terminated |
| Z-0735-2007 | AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The… | Roche Molecular Systems, Inc. | 03/09/2007Terminated |
| Z-0734-2007 | AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular DiagnosticsThe current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The… | Roche Molecular Systems, Inc. | 03/09/2007Terminated |