Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
021
|
Date of Entry 03/18/2009
|
FR Recognition Number
|
13-25
|
Standard | |
CLSI AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline |
|
Scope/AbstractThis document provides guidance for developing a protocol for validation of the Laboratory Information System (LIS) as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data. |
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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
|
Automated instrumentation under:
Part 862 Clinical Chemistry and Clinical Toxicology Devices
Part 864 Hematology and Pathology Devices
Part 866 Immunology and Microbiology Devices |
|
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 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. |