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U.S. Department of Health and Human Services

Advisory Committees

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Clinical Chemistry and Clinical Toxicology Devices Panel - December 6, 2006

On December 6, 2006, the Clinical Chemistry and Clinical Toxicology Devices Panel discussed general issues concerning lipoprotein (HDL and LDL) subfraction assays. The Panel addressed potential uses of the assays, potential impact on treatment, how to establish accuracy and determine reference ranges, and lack of standardization and any risk this may cause to patients. The Panel also considered the value of particle size versus particle number in assessing lipid subfractions.

In general, the Panel felt lipid subfractions have some utility in assessing a patient's risk of developing cardiovascular disease and in aiding in the diagnosis of dyslipidemia, with certain populations. However, they felt that the tests should be used in conjunction with other traditional risk assessment tools and clinical judgment.

Contact: Veronica Calvin, Executive Secretary, at 240-276-0491 ext 161 or veronica.calvin@fda.hhs.gov.

Transcripts of this meeting may be purchased from:

Neal R. Gross
Court Reporters and Transcribers
1323 Rhode Island Ave., N.W.
Washington , D.C.
202-234-4433 or 800-473-1433

and

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane , Rockville, MD 20857
301-443-1726