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) → DOF — Lead, Atomic Absorption

# DOF · Lead, Atomic Absorption

_Clinical Toxicology · 21 CFR 862.3550 · Class 2_

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

## Overview

- **Product Code:** DOF
- **Device Name:** Lead, Atomic Absorption
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K142705](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K142705.md) | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | Jul 7, 2015 | SESE |
| [K123563](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K123563.md) | LEADCARE (R)  ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Magellan Diagnostics | Aug 20, 2013 | SESE |
| [K052549](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K052549.md) | LEADCARE II BLOOD LEAD TESTING SYSTEM | Esa Biosciences, Inc. | Oct 6, 2005 | SESE |
| [K971640](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K971640.md) | LEADCARE BLOOD LEAD TESTING SYSTEM | Esa, Inc. | Sep 9, 1997 | SESE |
| [K936060](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K936060.md) | ATOMSPEC GF BLOOD LEAD WORKSTATION | Thermo Jarrell Ash Corp.Div.Thermo Inst. | Sep 6, 1994 | SESE |
| [K843839](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOF/K843839.md) | STAT/PB REAGENT | Tri-Tech, Inc. | Jan 3, 1985 | SESE |

## Top Applicants

- Magellan Diagnostics — 2 clearances
- Esa Biosciences, Inc. — 1 clearance
- Esa, Inc. — 1 clearance
- Thermo Jarrell Ash Corp.Div.Thermo Inst. — 1 clearance
- Tri-Tech, Inc. — 1 clearance

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

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