FDA Product Code SBP: 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) 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.
Leading manufacturers include Cepheid.
FDA 510(k) Cleared Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test Devices (Product Code SBP)
About Product Code SBP - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBP since 2024, with 0 receiving FDA clearance (average review time: 72 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →