Enzyme Immunoassay, Oxcarbazepine Metabolite
The Enzyme Immunoassay, Oxcarbazepine Metabolite (product code POX) is a Class 2 clinical toxicology in vitro diagnostic device intended for the quantitative determination of the oxcarbazepine metabolite in human serum to monitor drug levels and help ensure appropriate therapy, regulated under 862.3645. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POX
- Device Class
- FDA class 2
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | Aug 09, 2016 | Substantially Equivalent | Ark Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.