| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
021
|
Date of Entry 03/18/2009
|
|
FR Recognition Number
|
13-28
|
| Standard | |
CLSI AUTO9-A
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
|
| Extent of Recognition
|
Rationale for Recognition
| This document provides a standard communication protocol for instrument system vendors, device manufacturers, and hospital administrators to allow remote connections to laboratory diagnostic devices. The remote connections can be used to monitor instruments' subsystems; collect diagnostics data for remote system troubleshooting; and collect data for electronic inventory management. |
|
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
|
|
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 |
|
| *These are provided as examples and others may be applicable. |
