FDA product code SBP: Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
SBP is the FDA product code for simple point-of-care nucleic acid-based hepatitis c virus ribonucleic acid test. It is a Class II device, regulated under 21 CFR 866.3171 and reviewed by the Microbiology panel. Devices under SBP reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3171 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for SBP devices
openFDA lists no recalls for product code SBP.
Frequently asked questions
What is FDA product code SBP?
SBP is the FDA product code for simple point-of-care nucleic acid-based hepatitis c virus ribonucleic acid test. It is a Class II device, regulated under 21 CFR 866.3171 and reviewed by the Microbiology panel.
What device class is SBP?
Class II, regulation 21 CFR 866.3171. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SBP
- Run a recall and safety report across every SBP manufacturer
- Watch product code SBP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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