| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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7-329
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| Standard | |
CLSI EP06-EG 2nd Edition
Developer Validation of Linearity, Establishment Guide |
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Scope/Abstract| CLSI EP06 provides essential guidance for validating and verifying the linearity of a measurement procedure's analytical measuring interval (AMI). This guideline outlines minimum procedures for both manufacturers and laboratory-developed test (LDT) developers to confirm linearity claims and ensure measurement accuracy. EP06 helps laboratories meet medical and regulatory requirements while maintaining precision in quantitative testing. |
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| Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR 58 Good Laboratory Practice for Non Clinical Studies |
| 21 CFR 820 Quality Systems Regulations |
|
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative 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. |
