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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 7-331
Standard
CLSI  AUTO02-A2
Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
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
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
§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 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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