title: Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data.
authors.affiliation: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. james.callaghan@fda.hhs.gov
authors.forename: James V
authors.initials: JV
authors.lastname: Callaghan
authors.forename: Steven I
authors.initials: SI
authors.lastname: Gutman
mesh_terms: D015415:Biomarkers / Q000032:analysis; D002097:C-Reactive Protein / Q000032:analysis* / Q000592:standards; D019963:Clinical Chemistry Tests / Q000592:standards*; D003327:Coronary Disease / Q000175:diagnosis*; D006801:Humans; D017410:Practice Guidelines as Topic; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D002097:C-Reactive Protein