De Novo · Granted
GrantedXpert HCV; GeneXpert Xpress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
Granted on Jun 27, 2024 as a new device type through De Novo after a 72-day review.
- Decided
- Jun 27, 2024
- Review
- 72 days
- Class
- Class II
- Product code
- SBP
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SBP devicesSBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBP
Too few SBP 510(k)s in any year since 2007 to give a median.
Recalls per year · SBP
No recall names SBP since 2007.
Adverse event reports per year · SBP
No MAUDE report names SBP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240016 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240016: Xpert HCV; GeneXpert Xpress System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026