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) → DIE — Heavy Metals Control Materials

# DIE · Heavy Metals 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/DIE

## Overview

- **Product Code:** DIE
- **Device Name:** Heavy Metals 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K020610](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K020610.md) | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Bio-Rad | Apr 22, 2002 | SESE |
| [K990928](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K990928.md) | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Bio-Rad | Apr 16, 1999 | SESE |
| [K891691](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K891691.md) | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | Bio-Rad | Dec 19, 1989 | SESE |
| [K890721](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K890721.md) | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Actio, Inc. | Apr 10, 1989 | SESE |
| [K863915](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIE/K863915.md) | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Shape Products Co. | Nov 24, 1986 | SESE |

## Top Applicants

- Bio-Rad — 3 clearances
- Actio, Inc. — 1 clearance
- Shape Products Co. — 1 clearance

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

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