Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number	040	Date of Entry 08/14/2015
FR Recognition Number	7-252
Standard
CLSI  EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
Scope/Abstract This guideline provides protocols that can evaluate commutability in any nonpatient processed samples when tested using quantitative measurement procedures. Such processed samples may be used for proficiency testing/external quality assessment (PT/EQA), measuring interval verification sample sets, or QC samples. The guideline is intended to be used by developers of commercial diagnostic tests as well as laboratory-developed tests, manufacturers of measuring interval sample sets and QC samples, and PT or EQA providers. This guideline may also be useful to all clinical laboratory professionals wishing to investigate a processed sample's commutability.
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  Nisar Pampori   FDA/OC/CDRH/OPEQ/OIDRH/DIHD/IMFB/   301-796-6144   nisar.pampori@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.