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 862.3880](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3880) → LEW — Thin Layer Chromatography, Theophylline

# LEW · Thin Layer Chromatography, Theophylline

_Clinical Toxicology · 21 CFR 862.3880 · Class 2_

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

## Overview

- **Product Code:** LEW
- **Device Name:** Thin Layer Chromatography, Theophylline
- **Regulation:** [21 CFR 862.3880](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3880)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K771120](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEW/K771120.md) | IMPREFLEX ALGINATE IMPRESSION MATERIAL | Espe Dental Products | Aug 3, 1977 | SESE |

## Top Applicants

- Espe Dental Products — 1 clearance

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

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