Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)
FDA 510(k) K093420 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, Ontario, CA - Received
- November 3, 2009
- Decision date
- August 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTI – Drug Metabolizing Enzyme Genotyping Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3360
- Specialty
- 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.
Other 510(k)s with product code NTI
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|---|---|---|---|
| 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 |
| 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 |
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| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/30/2018SE |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/30/2018SE |
| K170492 | xTAG CYP2D6 Kit v3NTI · Special | 08/11/2017SE |
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Questions and answers
When was Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254) cleared by the FDA?
Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254) (K093420) received a 510(k) decision of Substantially Equivalent on August 26, 2010, 296 days after the submission was received.
What is the product code of K093420?
The FDA product code is NTI – Drug Metabolizing Enzyme Genotyping Systems, a Class II (moderate risk) device regulated under 21 CFR 862.3360.