LGI · Fluorescence Polarization Immunoassay, Carbamazepine
Clinical Toxicology · 21 CFR 862.3645 · Class 2
Overview
| Product Code | LGI |
|---|---|
| Device Name | Fluorescence Polarization Immunoassay, Carbamazepine |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944063 | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | Sigma Diagnostics, Inc. | Nov 10, 1994 | SESE |
| K940682 | AXSYM(TM) QUINIDINE | Abbott Laboratories | Jun 21, 1994 | SESE |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | Apr 12, 1990 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Innotron of Oregon, Inc. — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
