POX · Enzyme Immunoassay, Oxcarbazepine Metabolite
Clinical Toxicology · 21 CFR 862.3645 · Class 2
Overview
| Product Code | POX |
|---|---|
| Device Name | Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Regulation | 21 CFR 862.3645 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | Ark Diagnostics, Inc. | Aug 9, 2016 | SESE |
Top Applicants
- Ark Diagnostics, Inc. — 1 clearance
