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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 7-290
CLSI  EP34 1st Edition
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure's upper limit of quantitation.

Guidance is provided on determining, validating, and verifying the appropriate diluent and dilution ratio to be used for such specimens. This guideline also covers creating spiked samples for use during dilution recovery studies and using spiking to determine the suitability of a sample matrix for dilution recovery studies. The intended users of this guideline are manufacturers of in vitro diagnostic tests and medical laboratory scientists, directors, and pathologists.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Chapter 2: Establishing an Extended Measuring Interval Through Specimen Dilution and Spiking
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.

Standard is recognized on a scientific basis: device performance. This standard conflicts with an existing regulation.

Chapter 2 does not satisfy the requirement for analytical performance characteristics under 21 CFR 809.10(b)(12) Specific Performance Characteristics and 21 CFR 807.87 because it describes requirements for establishing the extended measuring interval at research and development stage and not for submitters of premarket submissions.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 809.10(b)(12)
21 CFR 807.87
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.
FDA Technical Contacts
 Marina V. Kondratovich
 Elizabeth Stafford
 Zhanna Shubin
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.