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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 7-246: CLSI POCT12-A3, point-of-care blood glucose testing in acute and chronic care facilities; approved guideline -- third edition. (InVitro Diagnostics)

Date of Standard: 2013. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
Devices Affected:
All Ancillary (Bedside) Blood Glucose Testing Devices
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
Relevant Guidance:
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket

Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems

Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
 Patricia Bernhardt
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5654
  Silver Spring MD 20993
  301/796-6136
  email: patricia.bernhardt@fda.hhs.gov
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