eSensor Warfarin Sensitivity Saliva Test
FDA 510(k) K152612 · Genmark Diagnostics, Incorporated
510(k) numberK152612
Submission
- Device name
- eSensor Warfarin Sensitivity Saliva Test
- Applicant
- Genmark Diagnostics, Incorporated
Carlsbad, CA, US - Received
- September 14, 2015
- Decision date
- May 26, 2016
- 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.
Other 510(k)s with product code ODW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183530 | TruDiagnosis SystemODW · Traditional | Akonni Biosystems, Inc. | 05/24/2019SE |
| 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 |
| K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestODW · Traditional | Nanosphere, Inc. | 09/17/2007SE |
More from Nanosphere, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/27/2022SE |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/12/2019SE |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelPEO · Traditional | 12/21/2018SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | 12/20/2018SE |
| K163652 | ePlex InstrumentNSU · Traditional | 06/09/2017SE |
| K163636 | ePlex Respiratory Pathogen PanelOCC · Traditional | 06/09/2017SE |
| K110786 | Esensor Warfarin Sensitivity Saliva TestNSU · Traditional | 12/02/2011SE |
Questions and answers
When was eSensor Warfarin Sensitivity Saliva Test cleared by the FDA?
eSensor Warfarin Sensitivity Saliva Test (K152612) received a 510(k) decision of Substantially Equivalent on May 26, 2016, 255 days after the submission was received.
What is the product code of K152612?
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.