ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
FDA 510(k) K153596 · Ark Diagnostics, Inc.
510(k) numberK153596
Submission
- Device name
- ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- Applicant
- Ark Diagnostics, Inc.
Fremont, CA, US - Received
- December 16, 2015
- Decision date
- August 9, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POX – Enzyme Immunoassay, Oxcarbazepine Metabolite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
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.
More from Ark Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232522 | ARK Levetiracetam II AssayORI · Traditional | 02/27/2024SE |
| K232017 | ARK Methotrexate II AssayLAO · Traditional | 12/20/2023SE |
| K231752 | ARK Hydrocodone AssayDJG · Traditional | 11/09/2023SE |
| K201089 | ARK Lacosamide AssayNWM · Traditional | 08/05/2021SE |
| K200197 | ARK Fentanyl II AssayDJG · Traditional | 02/26/2020SE |
| K182280 | ARK Tramadol AssayDJG · Traditional | 12/10/2018SE |
| K182779 | ARK EDDP AssayDJR · Traditional | 11/21/2018SE |
| K180427 | ARK Fentanyl AssayDJG · Traditional | 06/06/2018SE |
| K163359 | ARK Methotrexate AssayLAO · Special | 08/18/2017SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | 10/18/2011SE |
Questions and answers
When was ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control cleared by the FDA?
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (K153596) received a 510(k) decision of Substantially Equivalent on August 9, 2016, 237 days after the submission was received.
What is the product code of K153596?
The FDA product code is POX – Enzyme Immunoassay, Oxcarbazepine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3645.