xTAG CYP2D6 Kit v3
FDA 510(k) K170492 · Luminex Molecular Diagnostics, Inc.
510(k) numberK170492
Submission
- Device name
- xTAG CYP2D6 Kit v3
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, CA - Received
- February 17, 2017
- Decision date
- August 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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.
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| 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 |
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| 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 |
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| 510(k) | Device | Decision |
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| K242613 | NxTAG® Respiratory Pathogen PanelOCC · Special | 10/02/2024SE |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF · Traditional | 03/11/2024SE |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Special | 12/11/2019SE |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP)PCH · Special | 11/12/2019SE |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/04/2019SE |
| 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 |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2NUA · Special | 12/15/2016SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special | 12/15/2016SESK |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Traditional | 12/17/2015SE |
Questions and answers
When was xTAG CYP2D6 Kit v3 cleared by the FDA?
xTAG CYP2D6 Kit v3 (K170492) received a 510(k) decision of Substantially Equivalent on August 11, 2017, 175 days after the submission was received.
What is the product code of K170492?
The FDA product code is NTI – Drug Metabolizing Enzyme Genotyping Systems, a Class II (moderate risk) device regulated under 21 CFR 862.3360.