| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
009
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Date of Recognition 03/08/2004
|
|
FR Recognition Number
|
7-88
|
StandardCLSI C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
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Scope/Abstract| This guideline details procedures for the manufacture and evaluation of human serum pools for cholesterol measurement. |
|
| Extent of Recognition
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
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