K153596 is an FDA 510(k) clearance for the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control. This device is classified as a Enzyme Immunoassay, Oxcarbazepine Metabolite (Class II - Special Controls, product code POX).
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 9, 2016, 237 days after receiving the submission on December 16, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645. An Oxcarbazepine Metabolite Assay Is An Enzyme Immunoassay Intended For The Quantitative Determination Of Oxcarbazepine Metabolite In Human Serum. The Measurements Obtained Are Used In Monitoring Levels Of Oxcarbazepine Metabolite To Help Ensure Appropriate Therapy..
| 510(k) Number | K153596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2015 |
| Decision Date | August 09, 2016 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | POX - Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |
| Definition | An Oxcarbazepine Metabolite Assay Is An Enzyme Immunoassay Intended For The Quantitative Determination Of Oxcarbazepine Metabolite In Human Serum. The Measurements Obtained Are Used In Monitoring Levels Of Oxcarbazepine Metabolite To Help Ensure Appropriate Therapy. |