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 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550) → DIJ — Lead, Delta Amino Levulinic Acid

# DIJ · Lead, Delta Amino Levulinic Acid

_Clinical Toxicology · 21 CFR 862.3550 · Class 2_

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

## Overview

- **Product Code:** DIJ
- **Device Name:** Lead, Delta Amino Levulinic Acid
- **Regulation:** [21 CFR 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K030826](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIJ/K030826.md) | PRECISET DAT AMPHETAMINE | Quantimetrix Corp. | Apr 3, 2003 | SESE |
| [K792407](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIJ/K792407.md) | ELVI-AMINOLEVULINIC ACID | Volu Sol Medical Industries | Jan 16, 1980 | SESE |

## Top Applicants

- Quantimetrix Corp. — 1 clearance
- Volu Sol Medical Industries — 1 clearance

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

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