K152612 is an FDA 510(k) clearance for the eSensor Warfarin Sensitivity Saliva Test. This device is classified as a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II - Special Controls, product code ODW).
Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on May 26, 2016, 255 days after receiving the submission on September 14, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3360. 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..
| 510(k) Number | K152612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2015 |
| Decision Date | May 26, 2016 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | ODW - Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3360 |
| Definition | 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. |