# K243489: Alinity m EBV (09N43-095)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Jul 28, 2025 after 258 days
- Product code: QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna)
- Device class: 2
- Regulation: 21 CFR 866.3183
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200015 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Abbott Molecular, Inc. (2022) Summary page 6.

## Indications for use
Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Epstein-Barr Virus (EBV) DNA in human EDTA plasma on the automated Alinity m System. Alinity m EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV is not cleared for use as a screening test for donors of blood, blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for EBV.

Source page: https://510kreport.com/device/K243489
Methodology: https://510kreport.com/methodology