| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
7-337
|
| Standard | |
CLSI AUTO08-A
Managing and Validating Laboratory Information Systems; Approved Guideline |
|
Scope/Abstract| This 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. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
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)
| InVitro Diagnostics (primary) |
| Software/Informatics |
|
| *These are provided as examples and others may be applicable. |
