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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 029 Date of Entry 08/20/2012 
FR Recognition Number 13-31
Standard
CLSI  AUTO12-A
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
Scope/Abstract
Clinical and Laboratory Standards Institute document AUTO12-A--Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard was developed to reduce the unacceptably high incidence of mislabeled specimens in clinical laboratories. The standard specifies locations and formats for the required human-readable elements that must appear on the label for each clinical laboratory specimen (except labels with limited space, eg, slides and pediatric specimens), a standard label of 2 x 1 inches (50.8 x 25.4 mm), and an exact required location and format on this label for other commonly used elements. The patient's name is judged to be the single most important element in correct specimen identification and is always to be in the top left corner on each label. The standard also specifies rules for truncation for long patient names, the location and of the bar code on each label, a list of the most commonly used variable elements that can appear on specimen labels, and the required orientation of labels on specimen tubes.
Extent of Recognition
Complete standard
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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