Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

040

Date of Entry 08/14/2015 

FR Recognition Number

7-253

Standard

CLSI  EP15-A3 (Reaffirmed: September 2019)
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition

Scope/Abstract

This document describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
21 CFR 862, 864 and 866 devices and their associated product code devices and 21 CFR 809
21 CFR HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES

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   FDA/CDRH/OPEQ/OIDRH/   301-796-6036   marina.kondratovich@fda.hhs.gov

Qin Li   FDA/OC/CDRH/OPEQ/OCEA/DCEAII/   301-796-5311   qin.li@fda.hhs.gov

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.