title: Improving the 510(k) FDA process for cardiac troponin assays: in search of common ground.
authors.affiliation: Department of Laboratory Medicine and Pathology, Hennepin County Medical Center and Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN; apple004@umn.edu.
authors.forename: Fred S
authors.initials: FS
authors.lastname: Apple
authors.affiliation: Department of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA;
authors.forename: Judd
authors.initials: J
authors.lastname: Hollander
authors.affiliation: Department of Laboratory Medicine, University of California, San Francisco, CA;
authors.forename: Alan H B
authors.initials: AH
authors.lastname: Wu
authors.affiliation: Cardiovascular Division in the Department of Internal Medicine and CCLS Division in the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
authors.forename: Allan S
authors.initials: AS
authors.lastname: Jaffe
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods / Q000592:standards; D002624:Chemistry, Clinical / Q000331:legislation & jurisprudence* / Q000379:methods*; D006331:Heart Diseases / Q000097:blood*; D006801:Humans; D057230:Limit of Detection; D017410:Practice Guidelines as Topic / Q000592:standards*; D014336:Troponin / Q000097:blood*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D014336:Troponin