Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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030
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Date of Entry 01/15/2013
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FR Recognition Number
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7-233
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Standard | |
CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition |
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Scope/AbstractThis document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers? detection capability claims, and for the proper use and interpretation of different detection capability estimates. |
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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 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. |