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Recognized Consensus Standards

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Recognition List Number: 032 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 13-58: IEEE / ISO 11073-10417 First edition 2010-05-01, health informatics - personal health device communication - part 10417: device specialization - glucose meter. (Software/Informatics)

Date of Standard: 2010. 
Addresses of Standards Development Organizations:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
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:
Glucose meters including the following devices:
System, test, blood glucose, over the counter
Glucose dehydrogenase, glucose
Glucose oxidase, glucose
Sensor, glucose, invasive
Artificial pancreas device system, threhold suspend
Processes Affected:
510(k), PMA
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Artificial Pancreas Device System, Threshold Suspend Class 3 OZO
Unclassified Sensor, Glucose, Invasive Class 3 MDS
§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:
ISO 15197 First edition 2003-05-01, In Vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
FDA Technical Contacts:
 James Mullally
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5613
  Silver Spring MD 20993
  240/402-5021
  email: james.mullally@fda.hhs.gov
 Catherine Li
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3435
  Silver Spring MD 20993
  301/796-6304
  email: catherine.li@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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