510(k) DEN240016
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 27, 2024
- Date Received
- April 16, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
- Device Class
- Class II
- Regulation Number
- 866.3171
- Review Panel
- MI
- Submission Type
A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the diagnosis of HCV infection or as an aid in the management of HCV-infected patients, including individuals without antibodies to HCV. This device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The test is not intended for use as a donor screening test for the presence of HCV RNA in blood, blood products, or tissue donors.