Improving the 510(k) FDA process for cardiac troponin assays: in search of common ground

MeSH terms

• Blood Chemical Analysis / methods
• Blood Chemical Analysis / standards
• Chemistry, Clinical / legislation & jurisprudence*
• Chemistry, Clinical / methods*
• Heart Diseases / blood*
• Humans
• Limit of Detection
• Practice Guidelines as Topic / standards*
• Troponin / blood*
• United States
• United States Food and Drug Administration