Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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7-252
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Standard | |
CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |