Verigene CYP2C19 Nucleic Acid Tes (2C19)
FDA 510(k) K120466 · Nanosphere, Inc.
510(k) numberK120466
Submission
- Device name
- Verigene CYP2C19 Nucleic Acid Tes (2C19)
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- February 15, 2012
- Decision date
- November 6, 2012
- 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 |
| 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 |
More from Roche Molecular Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)OCC · Traditional | 09/04/2015SE |
| K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( Ep)PCH · Traditional | 06/20/2014SE |
| K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)PEN · Traditional | 01/08/2014SE |
| K123197 | Verigene C. Difficile Nucleic Acid Test (CDF)OZN · Traditional | 12/05/2012SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | 09/19/2012SE |
| K112424 | Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)NQX · Traditional | 12/16/2011SE |
| K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)OCC · Traditional | 01/10/2011SE |
| K093337 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP SystemOCC · Special | 11/17/2009SE |
| K092957 | Verigene System, Verigene Respiratory Virus Nucleic Acid TestOCC · Special | 10/21/2009SE |
| K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)OCC · Traditional | 10/09/2009SE |
Questions and answers
When was Verigene CYP2C19 Nucleic Acid Tes (2C19) cleared by the FDA?
Verigene CYP2C19 Nucleic Acid Tes (2C19) (K120466) received a 510(k) decision of Substantially Equivalent on November 6, 2012, 265 days after the submission was received.
What is the product code of K120466?
The FDA product code is NTI – Drug Metabolizing Enzyme Genotyping Systems, a Class II (moderate risk) device regulated under 21 CFR 862.3360.