DEN240016 is an FDA 510(k) submission for the Xpert HCV. This device is classified as a Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test (Class II - Special Controls, product code SBP).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on June 27, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3171. 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) Number | DEN240016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 16, 2024 |
| Decision Date | June 27, 2024 |
| Days to Decision | 72 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | SBP — Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3171 |
| 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. |