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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 016 FR Publication Date: 11/03/2006 

Part B: Supplementary Information

Recognition Number 7-48: CLSI / NCCLS T/DM06-A, blood alcohol testing in the clinical laboratory; approved guideline (1997). (InVitro Diagnostics)

Date of Standard: 1997. 
Addresses of Standards Development Organizations:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
 National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Blood Alcohol Testing
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC
§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
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
 Douglas Rheinheimer
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5624
  Silver Spring MD 20993
  301/796-6157
  email: douglas.rheinheimer@fda.hhs.gov
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