Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceHepQuant SHUNT® Liver Diagnostic Test
Generic NameTest for Esophageal Varices
ApplicantHepquant, LLC
12635 E. Montview Blvd., Suite 175l1
Aurora, CO 80045
PMA NumberP220016
Date Received09/14/2022
Decision Date06/18/2026
Product Code SIO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03583996
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order 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.
-
-