Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test
FDA 510(k) K070804 · Nanosphere, Inc.
510(k) numberK070804
Submission
- Device name
- Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test
- Applicant
- Nanosphere, Inc.
Northbrook, IL, US - Received
- March 23, 2007
- Decision date
- September 17, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODW – Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3360
- Specialty
- Clinical Toxicology
An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
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|---|---|---|---|
| K183530 | TruDiagnosis SystemODW · Traditional | Akonni Biosystems, Inc. | 05/24/2019SE |
| K152612 | eSensor Warfarin Sensitivity Saliva TestODW · Traditional | Genmark Diagnostics, Incorporated | 05/26/2016SE |
| K073071 | Eq-Prc LC Warfarin Genotyping KitODW · Traditional | Trimgen Corporation | 02/06/2009SE |
| K073720 | Esensor Warfarin Sensitivity and XT-8 InstrumentODW · Traditional | Osmetech Molecular Diagnostics | 07/17/2008SE |
| K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinODW · Abbreviated | Autogenomics, Incorporated | 01/23/2008SE |
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Questions and answers
When was Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test cleared by the FDA?
Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test (K070804) received a 510(k) decision of Substantially Equivalent on September 17, 2007, 178 days after the submission was received.
What is the product code of K070804?
The FDA product code is ODW – Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System, a Class II (moderate risk) device regulated under 21 CFR 862.3360.