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) → DKC — Alcohol Control Materials

# DKC · Alcohol 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/DKC

## Overview

- **Product Code:** DKC
- **Device Name:** Alcohol 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K031392](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K031392.md) | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Medical Analysis Systems, Inc. | Jul 1, 2003 | SESE |
| [K935819](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K935819.md) | QUALITY CONTROL MATERIAL (ASSAYED) | Columbia Diagnostics, Inc. | Mar 22, 1994 | SESE |
| [K933425](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K933425.md) | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | Sigma Diagnostics, Inc. | Nov 16, 1993 | SESE |
| [K934467](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K934467.md) | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Beckman-Diagnostic Systems Group | Oct 27, 1993 | SESE |
| [K932067](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K932067.md) | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | Sigma Diagnostics, Inc. | Jun 16, 1993 | SESE |
| [K912827](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K912827.md) | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Cala Diagnostics | Aug 12, 1991 | SESE |
| [K912826](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K912826.md) | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Cala Diagnostics | Jul 26, 1991 | SESE |
| [K843872](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K843872.md) | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | Sigma Chemical Co. | Oct 31, 1984 | SESE |
| [K833514](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K833514.md) | TOXI CHEM SERUM ALCOHOL CONTROL | Fisher Diagnostics | Dec 8, 1983 | SESE |
| [K810465](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K810465.md) | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | Syva Co. | Mar 6, 1981 | SESE |
| [K802618](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKC/K802618.md) | EMIT-STM ETHYL ALCOHOL URINE CONTROLS | Syva Co. | Oct 31, 1980 | SESE |

## Top Applicants

- Cala Diagnostics — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- Syva Co. — 2 clearances
- Beckman-Diagnostic Systems Group — 1 clearance
- Columbia Diagnostics, Inc. — 1 clearance

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

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