DEN200015 is an FDA 510(k) submission for the cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit. This device is classified as a Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna (Class II - Special Controls, product code QLX).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on July 30, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3183. A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings..
| 510(k) Number | DEN200015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 02, 2020 |
| Decision Date | July 30, 2020 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QLX — Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3183 |
| Definition | A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings. |