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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 045 Date of Entry 09/21/2016 
FR Recognition Number 7-265
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
This document provides guidance to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. This guideline emphas particular areas related to assay development and presents a standardized approach for method verification that is specific to mass spectrometry technology.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 7.5.1; Dependent on the analyte, additional studies may be required. Consult technical contacts prior to conducting these studies to discuss appropriate analytical test performance.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 862 Clinical Chemistry and Clinical Toxicology Devices
21 CFR 864 Hematology and Pathology Devices
21 CFR 866 Immunology and Microbiology Devices
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.

CLSI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

CLSI EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.

CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition.

CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition.

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 Contact
 Jinong Li
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.