21 CFR 866.3171 — Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3171
Identification
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 is evidence of active infection.
Classification Rationale
Class II (special controls). The device is a simple point-of-care nucleic acid-based hepatitis C virus ribonucleic acid test.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SBP | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | 2 | 1 |
