title: The challenges and concerns companies face pertaining to the US Food and Drug Administration 510(k) process for cardiac biomarkers.
authors.affiliation: Hennepin County Medical Center, Minneapolis, MN 55415, USA. apple004@umn.edu
authors.forename: Fred S
authors.initials: FS
authors.lastname: Apple
authors.forename: David
authors.initials: D
authors.lastname: Morrow
authors.forename: Christian
authors.initials: C
authors.lastname: Zaugg
authors.forename: David
authors.initials: D
authors.lastname: Hickey
authors.forename: Michelle
authors.initials: M
authors.lastname: Zaharik
authors.forename: John J
authors.initials: JJ
authors.lastname: Blackwood
authors.forename: Kirsten
authors.initials: K
authors.lastname: Jakobsen
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis; D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006331:Heart Diseases / Q000175:diagnosis*; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000097:blood*; D020107:Troponin T / Q000097:blood*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic; D019210:Troponin I; D020107:Troponin T