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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 020 Date of Entry 09/09/2008 
FR Recognition Number 13-9
Standard
CLSI  AUTO2-A2
Laboratory Automation: Bar Codes for Specimen Container Identification
Scope/Abstract
Clinical and Laboratory Standards Institute document AUTO2-A2 - Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard - Second Edition defines the way bar-coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar-code labels on specimen container tubes that are used on clinical laboratory analyzers. However, due to the current diversity of patient data, the informational content that is used to identify the specimen has not been specified. This specification will also meet the requirement for laboratory automation systems. It enables the production of reliable bar-coded symbols that are readable by any complying clinical laboratory analyzer and automation system.
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
§864.3250 Container, Specimen, Sterile Class 1 FMH
§864.3250 Container, Specimen Mailer And Storage, Sterile Class 1 KDT
§864.3250 Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Class 1 KDW
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 Contact
 Yan Zhang
  CDRH/OPEQ/OHTVII/DMGP/MGB
  301-837-7386
  yan.zhang1@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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