| IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 13-93 |
| Extent | Complete standard |
| Standards Orgs | IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/ |
| STG | Software/Informatics |
| FDA Tech | Joshua Balsam FDA/OMPT/CDRH/OIR/DCTD/DDDB/ 240-402-6521 joshua.balsam@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.7675 | Test, Urine Leukocyte | Class 1 | LJX |
| §864.6550 | Blood, Occult, Colorimetric, In Urine | Class 2 | JIO |
| §862.1785 | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | CDM |
| §862.1645 | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | JIR |
| §862.1550 | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | CEN |
| §862.1510 | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | JMT |
| §862.1435 | Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | JIN |
| §862.1340 | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class 2 | JIL |
| §862.1115 | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | JJB |
| There is no relevant guidance developed at this time. |