The challenges and concerns companies face pertaining to the US Food and Drug Administration 510(k) process for cardiac biomarkers

Clin Chem. 2012 Jan;58(1):31-8. doi: 10.1373/clinchem.2011.165860. Epub 2011 Nov 17.
No abstract available

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnosis
  • Biomarkers / blood
  • Clinical Trials as Topic / legislation & jurisprudence
  • Drug Industry / legislation & jurisprudence*
  • Government Regulation*
  • Heart Diseases / diagnosis*
  • Humans
  • Myocardial Infarction / diagnosis
  • Reagent Kits, Diagnostic
  • Reference Values
  • Sensitivity and Specificity
  • Troponin I / blood*
  • Troponin T / blood*
  • United States
  • United States Food and Drug Administration

Substances

  • Biomarkers
  • Reagent Kits, Diagnostic
  • Troponin I
  • Troponin T