Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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7-291
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Standard | |
CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition |
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Scope/AbstractThis guideline describes what an error grid is, why it is useful, and how to construct and interpret the information. Guidance is provided for manufacturers and for the clinical laboratory. |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
5.9 Goals or Acceptance Criteria
5.10.2 Sample
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Sections 5.9 and 5.10.2 are in conflict with another recognized standard. See CLSI EP21 2nd Edition, ID Section, listed below. |
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Transition Period
FDA recognition of CLSI EP27-A [Rec# 7-291] will be superseded by recognition of CLSI EP27 [Rec# 7-313]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-291] until December 17, 2024. After this transition period, declarations of conformity to [Rec# 7-291] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures.
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. |