DKC · Alcohol Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | DKC |
|---|---|
| Device Name | Alcohol Control Materials |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
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 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Medical Analysis Systems, Inc. | Jul 1, 2003 | SESE |
| K935819 | QUALITY CONTROL MATERIAL (ASSAYED) | Columbia Diagnostics, Inc. | Mar 22, 1994 | SESE |
| K933425 | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | Sigma Diagnostics, Inc. | Nov 16, 1993 | SESE |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Beckman-Diagnostic Systems Group | Oct 27, 1993 | SESE |
| K932067 | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | Sigma Diagnostics, Inc. | Jun 16, 1993 | SESE |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Cala Diagnostics | Aug 12, 1991 | SESE |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Cala Diagnostics | Jul 26, 1991 | SESE |
| K843872 | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | Sigma Chemical Co. | Oct 31, 1984 | SESE |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | Fisher Diagnostics | Dec 8, 1983 | SESE |
| K810465 | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | Syva Co. | Mar 6, 1981 | SESE |
| K802618 | 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
