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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 009 Date of Recognition 03/08/2004 
FR Recognition Number 7-88
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
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
§862.1475 Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl Class 1 LBT
§862.1475 Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Class 1 LBS
§862.1475 Ldl & Vldl Precipitation, Hdl Class 1 LBR
§862.1475 System, Test, Low Density, Lipoprotein Class 1 MRR
§862.1175 Acid, Ferric Ion-Sulfuric, Cholesterol Class 1 CHD
§862.1175 Enzymatic Esterase--Oxidase, Cholesterol Class 1 CHH
§862.1175 Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol Class 1 CGO
§862.1175 Lipoprotein, High Density, Hdl, Over The Counter Class 1 NAQ
§862.1150 Calibrator, Multi-Analyte Mixture Class 2 JIX
§862.1150 Calibrator, Secondary Class 2 JIT
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.
FDA Technical Contact
 Paula Caposino
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics