510(k) K153596
K153596 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control". The FDA issued a decision of Substantially Equivalent on August 9, 2016. The device falls under product code POX (Enzyme Immunoassay, Oxcarbazepine Metabolite), a Class II device regulated under 21 CFR 862.3645. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2016
- Date Received
- December 16, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Oxcarbazepine Metabolite
- Device Class
- Class II
- Regulation Number
- 862.3645
- Review Panel
- TX
- Submission Type
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.