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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 036 Date of Entry 07/09/2014 
FR Recognition Number 7-175
Standard
CLSI  C59-A
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
Scope/Abstract
This guideline describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1475 Apolipoproteins Class 1 MSJ
§866.5580 Alpha-1-Lipoprotein, Antigen, Antiserum, Control Class 2 DER
§866.5600 Lipoprotein, Low-Density, Antigen, Antiserum, Control Class 2 DFC
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 Contact
 Paula Caposino
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/CRDB/
  301-796-6160
  paula.caposino@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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