Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
020
|
Date of Entry 09/09/2008
|
FR Recognition Number
|
13-21
|
Standard | |
CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
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Scope/AbstractThis practice describes a system for collecting data, maintaining records, and reporting on the reliability of operating clinical laboratory computer systems. The reliability measure will be achieved by documenting the number, severity, cause, impact, and duration of the failures that a system experiences. This practice can be implemented with paper forms or computer records. |
|
Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
|
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. |
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FDA Technical Contacts
|
Standards Development Organization
|
FDA Specialty Task Groups (STG)
Software/Informatics (primary) |
InVitro Diagnostics |
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*These are provided as examples and others may be applicable. |