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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 009 FR Publication Date: 03/08/2004 

Part B: Supplementary Information

Recognition Number 7-88: NCCLS C37-A, preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. (InVitro Diagnostics)

Date of Standard: 1999. 
Address of Standards Development Organization:
 National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In Vitro Diagnostic devices for the measurement of total cholesterol, HDL cholesterol and LDL cholesterol in vitro diagnostic calibrator materials
Processes Affected:
510(K), PMA, PDP, IDE
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1150 Calibrator, Multi-Analyte Mixture Class 2 JIX
§862.1150 Calibrator, Secondary Class 2 JIT
§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
§862.1475 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
Relevant Guidance:
Guidance for 510(K)s on Cholesterol Tests for Clinical Laboratory, Physician's Office Laboratory, and Home Use Guidance for Industry - Abbreviated 510(K) Submissions for In Vitro Diagnostic Calibrators Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(K) Clearance.
FDA Technical Contact:
 Paula Caposino
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5648
  Silver Spring MD 20993
  301/796-6160
  email: paula.caposino@fda.hhs.gov
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