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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 7-48
Standard
CLSI  C60-A
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
Scope/Abstract
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC
§862.3040 Potassium Dichromate Specific Reagent For Alcohol Class 2 DMI
§862.3040 Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet Class 2 DMT
§862.3040 Potassium Dichromate, Alcohol Class 2 DOJ
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Douglas Rheinheimer
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/TB/
  301-796-6157
  douglas.rheinheimer@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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