K243489 is an FDA 510(k) clearance for the Alinity m EBV (09N43-095). 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 Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 28, 2025, 258 days after receiving the submission on November 12, 2024.
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 | K243489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | July 28, 2025 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |