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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 047 Date of Entry 08/21/2017 
FR Recognition Number 7-272
CLSI  C57 1st Edition (Reaffirmed: January 2020)
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
This document is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry (MS) in the measurement of androgens and estrogens. The primary objectives of this document are to provide guidance and establish uniform practices necessary for producing quality data for quantitation of androgens and estrogens. The guideline provides details specific to androgen and estrogen measurement procedures with respect to preexamination (preanalytical) considerations, MS technologies, measurement procedure and run validation, as well as postexamination (postanalytical) considerations.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Acceptability Criteria in Section 7.2.1.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1275 Estrogens (total, nonpregnancy) test system.
§862.1680 Testosterone test system.
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.

CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline - First 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.