Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 13-13
Standard
CLSI  AUTO5-A
Laboratory Automation: Electromechanical Interfaces; Approved Standard
Scope/Abstract
This document provides standards for the development of an electromechanical interface between instruments and specimen processing and handling devices used in automated laboratory testing procedures.
Extent of Recognition
Complete standard
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.
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)
Software/Informatics (primary)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
-
-