Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
The Nucleic Acid Amplification Test for the Quantitation of Epstein-Barr Virus (EBV) DNA is a quantitative viral nucleic acid test intended for prescription use in transplant patient management, detecting EBV DNA using specified specimen processing, amplification, and detection instrumentation. It is used as an aid in managing transplant patients with active EBV infection or those at risk for developing EBV infections, with results interpreted alongside other clinical and laboratory findings. This device is classified as FDA Class 2, meaning it requires 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code QLX, falls under regulation 866.3183, and is reviewed by the Microbiology specialty panel. The device is not an implant, not life-sustaining, and is not GMP exempt.
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Basic Information
- Product Code
- QLX
- Device Class
- FDA class 2
- Regulation Number
- 866.3183
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243489 | Alinity m EBV (09N43-095) | Jul 28, 2025 | Substantially Equivalent | Abbott Molecular, Inc. |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | Jul 15, 2022 | Substantially Equivalent | Abbott Molecular, Inc. |
| K203220 | cobas BKV | Jan 29, 2021 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Jul 30, 2020 | Unknown | Roche Molecular Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.