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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 040 Date of Entry 08/14/2015 
FR Recognition Number 7-252
Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
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
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.