Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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7-152
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Standard | |
CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
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Scope/AbstractThis document contains a protocol that optimizes the experimental design for the evaluation of qualitative tests, to better measure performance and provide a structured data analysis. |
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Extent of Recognition
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Relevant FDA Guidance and/or Supportive Publications*
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, Issued March 2007. |
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FDA Technical Contacts
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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. |