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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-93
Standard
IEEE  Std 11073-10422-2016
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
Scope/Abstract
Within the context of the ISO/IEEE 11073(TM) family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth urine analyzer devices and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth urine analyzers.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1115 Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Class 1 JJB
§862.1340 Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Class 2 JIL
§862.1435 Nitroprusside, Ketones (Urinary, Non-Quant.) Class 1 JIN
§862.1510 Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Class 1 JMT
§862.1550 Dye-Indicator, Ph (Urinary, Non-Quantitative) Class 1 CEN
§862.1645 Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Class 1 JIR
§862.1785 Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Class 1 CDM
§864.6550 Blood, Occult, Colorimetric, In Urine Class 2 JIO
§864.7675 Test, Urine Leukocyte Class 1 LJX
Relevant FDA Guidance and/or Supportive Publications*
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
 Joshua Balsam
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  240-402-6521
  joshua.balsam@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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