| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
046
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Date of Entry 12/23/2016
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|
FR Recognition Number
|
7-268
|
| Standard | |
CLSI EP21 2nd Edition (Replaces EP21-A)
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
|
Scope/Abstract| This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with patient specimens, and to assess it relative to a pre-established goal for clinical acceptability. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Table 1. |
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Transition Period
| FDA recognition of CLSI EP21 2nd Edition (Replaces EP21-A) [Rec# 7-268] will be superseded by recognition of CLSI EP21 3rd Edition (Replaces EP21-A) [Rec# 7-347]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-268] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-268] will not be accepted. |
|
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 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. |
