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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 064 Date of Entry 05/26/2025 
FR Recognition Number 7-339
Standard
CLSI  AUTO09-A
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
Scope/Abstract
The CLSI AUTO09 standard provides essential guidance for managing, validating, and ensuring the integrity of laboratory test data efficiently. Designed for laboratory professionals, IT specialists, and regulatory compliance teams, this standard outlines best practices for data handling and system validation to ensure seamless, reliable, and standardized handling of laboratory test data. Key features include: Best practices for data management and security Guidance on validation and verification of test results Standardized approaches for data exchange between systems Recommendations to enhance accuracy and efficiency
Extent of Recognition
Complete standard
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.
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
 Yan Zhang
  FDA/OC/CDRH/OPEQ/OHTVII/DMGP/MGB/
  301-837-7386
  yan.zhang1@fda.hhs.gov
 Thomas Miller
  FDA/OC/CDRH/OPEQ/OHTVII/DCTD/CB/
  240-402-8938
  Thomas.Miller@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Groups (STG)
InVitro Diagnostics (primary)
Software/Informatics
*These are provided as examples and others may be applicable.
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