510(k) K243489
K243489 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "Alinity m EBV (09N43-095)". The FDA issued a decision of Substantially Equivalent on July 28, 2025. The device falls under product code QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna), a Class II device regulated under 21 CFR 866.3183. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2025
- Date Received
- November 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Device Class
- Class II
- Regulation Number
- 866.3183
- Review Panel
- MI
- Submission Type
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.