Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
A simple point-of-care nucleic acid-based hepatitis C virus (HCV) RNA test is an in vitro diagnostic device intended for prescription use to detect HCV RNA in clinical specimens as an aid in diagnosing HCV infection or managing HCV-infected patients, including those without HCV antibodies; the device is simple to use without sample manipulation or transportation and is not intended for donor screening. It is classified as FDA Class II (510(k) required) under regulation 866.3171 in the Microbiology specialty, with product code SBP. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBP
- Device Class
- FDA class 2
- Regulation Number
- 866.3171
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240016 | Xpert HCV; GeneXpert Xpress System | Jun 27, 2024 | Unknown | Cepheid |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.