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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 13-10
Standard
CLSI  AUTO1-A
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
Scope/Abstract
This document provides standards for the design and manufacture of specimen containers and carriers used for collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory automation systems.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
 James Mullally
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/TB/
  240-402-5021
  james.mullally@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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