| Part B: Supplementary Information Sheet (SIS) |
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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/Abstract| This 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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Transition Period
| FDA recognition of CLSI EP12-A2 [Rec# 7-152] will be superseded by recognition of CLSI EP12 3rd Edition [Rec# 7-315]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-152] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 7-152] will not be accepted. |
|
Relevant FDA Guidance and/or Supportive Publications*
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, Issued March 2007.
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 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. |
