| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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7-349
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| Standard | |
CLSI EP35 2nd Edition
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
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Scope/AbstractCLSI EP35 provides recommendations on establishing clinical equivalence or suitability for multiple specimen types for a single measurement procedure. This guideline provides a protocol for assessing equivalence or suitability for use of a different specimen type compared with the established primary specimen type for a medical laboratory measurement procedure or qualitative examination. CLSI EP35 provides a general framework for studies that establish equivalence among similar-matrix specimen types and clinical suitability among dissimilar-matrix specimen types. It also includes instructions for laboratory verification of alternate specimen types for commercial measurement procedures. This guideline applies to both quantitative measurement procedures and qualitative examinations. The intended users of CLSI EP35 are manufacturers, developers of medical laboratory measurement procedures, and laboratorians verifying alternate specimen types.
CLSI EP35 is intended to be used for specimen types for which the desired measurand has a known clinical indication and for which adequate clinical information is available to establish risk-based clinical performance goals. Establishing clinically based performance goals is beyond the scope of CLSI EP35.
CLSI EP35 focuses on the effect of specimen type on the analytical measurement procedure. There may also be preanalytical factors between specimen types that can affect results. These differences may require additional studies to characterize their effect on the results. Such preanalytical factors are outside of the scope of CLSI EP35. |
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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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Transition Period
| FDA recognition of CLSI EP35, 1st Edition [Rec# 7-298] will be superseded by recognition of CLSI EP35 2nd Edition [Rec# 7-349]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-298] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-298] will not be accepted. |
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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 |
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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. |
