Alcohol Control Materials
FDA product code DKC · Class I (low risk) · 21 CFR 862.3280 · Clinical Toxicology
11510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | Medical Analysis Systems, Inc. | 07/01/2003SE |
| K935819 | Quality Control Material (Assayed)DKC · Traditional | Columbia Diagnostics, Inc. | 03/22/1994SE |
| K933425 | Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812DKC · Traditional | Sigma Diagnostics, Inc. | 11/16/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | Beckman-Diagnostic Systems Group | 10/27/1993SE |
| K932067 | Ethanol Controls, Urine, Levels 1,II, and IIIDKC · Traditional | Sigma Diagnostics, Inc. | 06/16/1993SE |
| K912827 | Serum Alcohol Control Levels 1, 2 & 3DKC · Traditional | Cala Diagnostics | 08/12/1991SE |
| K912826 | Whole Blood Alcohol Control, Level 1 & 2DKC · Traditional | Cala Diagnostics | 07/26/1991SE |
| K843872 | Ethanol Controls Low & High E5133/E5258DKC · Traditional | Sigma Chemical Co. | 10/31/1984SE |
| K833514 | Toxi Chem Serum Alcohol ControlDKC · Traditional | Fisher Diagnostics | 12/08/1983SE |
| K810465 | Emit-St Ethyl Alcohol Serum ControlsDKC · Traditional | Syva Co. | 03/06/1981SE |
| K802618 | Emit-Stm Ethyl Alcohol Urine ControlsDKC · Traditional | Syva Co. | 10/31/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3046-2020 Class II | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3042-2020 Class II | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3038-2020 Class II | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3037-2020 Class II | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3036-2020 Class II | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest…Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |