Levetiracetam Assay
The Levetiracetam Assay (product code ORI) is an in vitro diagnostic test for the quantitative determination of levetiracetam concentrations in human serum or plasma. Levetiracetam is an antiepileptic medication, and this assay supports therapeutic drug monitoring to aid in patient management. As an FDA Class 2 device under regulation 862.3350, it requires 510(k) premarket clearance and falls within the Clinical Toxicology specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
Research product code ORI in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- ORI
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
For the quantitative determination of levetiracetam in human serum or plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | Feb 27, 2024 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K091653 | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | Nov 02, 2009 | 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.