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) → LPX — Radioceptor Assay, Neuroleptic Drugs

# LPX · Radioceptor Assay, Neuroleptic Drugs

_Clinical Toxicology · 21 CFR 862.3645 · Class 2_

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

## Overview

- **Product Code:** LPX
- **Device Name:** Radioceptor Assay, Neuroleptic Drugs
- **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 (0 of 0)

_No cleared devices on record._

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

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