SBP — Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test Class II
FDA product code SBP covers "Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test", a Class II medical device regulated under 21 CFR 866.3171. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBP
- Device Class
- Class II
- Regulation Number
- 866.3171
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240016 | cepheid | Xpert HCV; GeneXpert Xpress System | June 27, 2024 |