| CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 7-48 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Douglas Rheinheimer FDA/OMPT/CDRH/OIR/DCTD/CTXB/ 301-796-6157 douglas.rheinheimer@fda.hhs.gov |
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The cost of alcohol abuse in our society is extraordinarily high in terms of the loss of human life, its detrimental contribution to the causes of illness and injury, productivity losses in the workplace, and the stress these in turn put on our medical resources and our judicial system. In a series of special workshops on alcoholism and alcohol abuse, the American Society of Clinical Pathologists Task Force on Drug Abuse and Toxicology1 recognized the magnitude of the problem of alcohol in our society. The title of these seminars was "Alcohol - The Second Great Imitator" because of the medical challenges in the diagnosis of this problem.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.3040 | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | Class 2 | DMT |
| §862.3040 | Potassium Dichromate Specific Reagent For Alcohol | Class 2 | DMI |
| §862.3040 | Potassium Dichromate, Alcohol | Class 2 | DOJ |
| §862.1145 | Cresolphthalein Complexone, Calcium | Class 2 | CIC |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |