Basic Information
- Trade Name
- HepQuant SHUNT® Liver Diagnostic Test
- PMA Number
- P220016
- Product Code
- SIO
- Generic Name
- Test for Esophageal Varices
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 18, 2026
- Date Received
- September 14, 2022
- Expedited Review
- N
Advisory Committee Statement
Approval for HepQuant SHUNT® Liver Diagnostic TestThe HepQuant SHUNT® Liver Diagnostic Test is designed for the quantitative detection of 13C-cholate and d4-cholate in human serum from blood samples collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The assay generates a Disease Severity Index (DSI) score from the clearance of 13C-cholate and d4-cholate. Sample analysis is conducted by the HepQuant Analytical Test Laboratory.A DSI score below the validated threshold can be used in patients with compensated cirrhosis (Child Pugh Class A), age 22 years or older, undergoing screening or surveillance for esophageal varices to identify those patients unlikely to have large esophageal varices. The DSI score aids in identifying patients unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing.The HepQuant SHUNT® Liver Diagnostic Test is not a stand-alone test and should be used in conjunction with other clinical and laboratory findings.