510(k) · Cleared
ClearedAlinity m EBV (09N43-095)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Cleared on Jul 28, 2025 as substantially equivalent to K212778 (Abbott Molecular, Inc., 2022) after a 258-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Jul 28, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- QLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200015 (2020). No later device cites it as a predicate yet.
- Root · 2 generations backDEN200015 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- 1 generation backK212778 Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit…Abbott Molecular, Inc. · 2022
- This deviceK243489 Alinity m EBV (09N43-095)Abbott Molecular, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020 | — |
| −1 | K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No.… | Abbott Molecular, Inc. | 2022 | — |
| 0 (this device) | K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QLX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLX device
- #1 K212778 Alinity m EBV AMP Kit (List No. 09N43-095)…score 6.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…Summary page 6…Predicate Device Device Name Predicate Device 510(k) Cleared Alinity m EBV Alinity m EBV K212778 07/15/2022 1.4 Device Description Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QLX devicesQLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QLX
Too few QLX 510(k)s in any year since 2007 to give a median.
Recalls per year · QLX
No recall names QLX since 2007.
Adverse event reports per year · QLX
2in 2025
MAUDE reports naming product code QLX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243489: Alinity m EBV (09N43-095).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243489
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026