Alinity m EBV (09N43-095)
FDA 510(k) K243489 · Abbott Molecular, Inc.
Submission
- Device name
- Alinity m EBV (09N43-095)
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- November 12, 2024
- Decision date
- July 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3183
- Specialty
- Microbiology
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…
Other 510(k)s with product code QLX
More from Roche Molecular Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252102 | Alinity m HCVMZP · Traditional | 09/25/2025SE |
| K243485 | Alinity m CMVPAB · Traditional | 07/01/2025SE |
| K241921 | Alinity m BKVQMI · Traditional | 03/24/2025SE |
| K241573 | Alinity m Resp-4-PlexQOF · Traditional | 02/14/2025SE |
| K243410 | simpli-COLLECT STI TestQYA · Traditional | 01/30/2025SE |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional | 12/06/2024SE |
| K233349 | Alinity m HSV 1 & 2 / VZVPGI · Traditional | 05/03/2024SE |
| K222379 | Alinity m STI AssayQEP · Traditional | 03/03/2023SE |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional | 07/15/2022SE |
| K202977 | Alinity m STI AssayQEP · Traditional | 04/29/2022SE |
Questions and answers
When was Alinity m EBV (09N43-095) cleared by the FDA?
Alinity m EBV (09N43-095) (K243489) received a 510(k) decision of Substantially Equivalent on July 28, 2025, 258 days after the submission was received.
What is the product code of K243489?
The FDA product code is QLX – Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna, a Class II (moderate risk) device regulated under 21 CFR 866.3183.