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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 7-270
Standard
CLSI  I/LA-20 3rd Edition (Replaces I/LA20-A3)
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
Scope/Abstract
This report provides guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human immunoglobulin E antibodies of defined allergen specificity.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.5510 Ige, Antigen, Antiserum, Control Class 2 DGC
§866.5510 Radioimmunoassay, Immunoglobulins (D, E) Class 2 JHR
§866.5750 System, Test, Radioallergosorbent (Rast) Immunological Class 2 DHB
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
 Sic Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/IMFB/
  301-796-7015
  sic.chan@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.
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