Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3645](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3645) → LGI — Fluorescence Polarization Immunoassay, Carbamazepine

# LGI · Fluorescence Polarization Immunoassay, Carbamazepine

_Clinical Toxicology · 21 CFR 862.3645 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI

## Overview

- **Product Code:** LGI
- **Device Name:** Fluorescence Polarization Immunoassay, Carbamazepine
- **Regulation:** [21 CFR 862.3645](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3645)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **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](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K944063.md) | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | Sigma Diagnostics, Inc. | Nov 10, 1994 | SESE |
| [K940682](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K940682.md) | AXSYM(TM) QUINIDINE | Abbott Laboratories | Jun 21, 1994 | SESE |
| [K900702](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI/K900702.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGI)

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