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 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280) → LAW — Theophylline Control Materials

# LAW · Theophylline Control Materials

_Clinical Toxicology · 21 CFR 862.3280 · Class 1_

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

## Overview

- **Product Code:** LAW
- **Device Name:** Theophylline Control Materials
- **Regulation:** [21 CFR 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280)
- **Device Class:** 1
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K920223](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAW/K920223.md) | CHEM CHEX THEOPHYLLINE CONTROL | Streck Laboratories, Inc. | Jun 10, 1992 | SESE |
| [K914251](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAW/K914251.md) | MODEL IRC PASSPORT NEBULIZER | Invacare Corp. | Jan 24, 1992 | SESE |
| [K903924](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAW/K903924.md) | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Biotrack, Inc. | Sep 17, 1990 | SESE |
| [K871589](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAW/K871589.md) | THEOPHYLLINE FPIA CONTROLS | Sigma Chemical Co. | Jun 17, 1987 | SESE |

## Top Applicants

- Biotrack, Inc. — 1 clearance
- Invacare Corp. — 1 clearance
- Sigma Chemical Co. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance

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

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