# DEN240016: Xpert HCV; GeneXpert Xpress System

- Pathway: De Novo (Direct)
- Applicant: Cepheid
- Decided: Jun 27, 2024 after 72 days
- Product code: SBP (Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test)
- Device class: 2
- Regulation: 21 CFR 866.3171
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Xpert HCV test, performed on the GeneXpert Xpress System, is an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hepatitis C Virus (HCV) RNA in human fingerstick K2-EDTA whole blood from adult individuals at risk and/or with signs and symptoms of HCV infection with or without antibody evidence of HCV infection. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic states of infection. The Xpert HCV test is not intended for monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors.

Source page: https://510kreport.com/device/DEN240016
Methodology: https://510kreport.com/methodology