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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 060 Date of Entry 05/29/2023 
FR Recognition Number 7-316
Standard
CLSI  NBS01 7th Edition
Dried Blood Spot Specimen Collection for Newborn Screening
Scope/Abstract
This standard describes the collection of blood specimens for newborn screening (NBS) programs, including equipment, sources of blood, collection sites, and techniques for blood spot specimen collection. This standard is intended to improve and ensure the quality of dried blood spot (DBS) specimens collected from newborns to rapidly identify newborns at risk for some congenital disorders (eg, inborn errors of metabolism, endocrinopathies, immunodeficiency disorders).
NBS01 includes detailed instructions for the preferred method of blood collection (heelstick with direct application) and also provides easy-to-follow illustrated instructions (see Appendix A) for the steps to be taken by personnel who work at facilities other than the NBS laboratory to ensure acceptable-quality blood spot specimens are collected and to prevent the need for specimen re-collection. Poor-quality specimens (shown in Appendix B) may result in false-positive or false-negative NBS test results and/or the inability to screen the baby. The need for re-collection results in additional follow-up, which if not completed in a timely manner, could result in a missed or delayed diagnosis, unnecessary trauma to the newborn, and anxiety to the parents or guardians.
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.
Transition Period
FDA recognition of CLSI NBS01-A6 (Replaces LA04-A5) [Rec# 7-244] will be superseded by recognition of CLSI NBS01 7th Edition [Rec# 7-316]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-244] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 7-244] will not be accepted.
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*
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
 Paula Caposino
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/CRDB/
  301-796-6160
  paula.caposino@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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