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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 009 Date of Entry 03/08/2004 
FR Recognition Number 7-88
Standard
CLSI  C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
Scope/Abstract
This guideline details procedures for the manufacture and evaluation of human serum pools for cholesterol measurement.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1150 Calibrator, Secondary Class 2 JIT
§862.1150 Calibrator, Multi-Analyte Mixture Class 2 JIX
§862.1175 Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol Class 1 CGO
§862.1175 Acid, Ferric Ion-Sulfuric, Cholesterol Class 1 CHD
§862.1175 Enzymatic Esterase--Oxidase, Cholesterol Class 1 CHH
§862.1175 Lipoprotein, High Density, Hdl, Over The Counter Class 1 NAQ
§862.1475 Ldl & Vldl Precipitation, Hdl Class 1 LBR
§862.1475 Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Class 1 LBS
§862.1475 Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl Class 1 LBT
§862.1475 System, Test, Low Density, Lipoprotein Class 1 MRR
Relevant FDA Guidance and/or Supportive Publications*
Guidance for 510(K)s on Cholesterol Tests for Clinical Laboratory, Physician's Office Laboratory, and Home Use Guidance for Industry, Issued February 1997.

Guidance for Industry - Abbreviated 510(K) Submissions for In Vitro Diagnostic Calibrators, Issued February 1999.

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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