SBP

Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

Product code

SBP

Device name

Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

Device class

Class 2

21 CFR

21 CFR 866.3171

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-06-27.