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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-244
Standard
CLSI NBS01-A6 (Replaces LA04-A5)
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
Scope/Abstract
This document highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.
FDA Technical Contact
 Kellie Kelm
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6145
  kellie.kelm@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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