FDA product code QLX: Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
QLX is the FDA product code for nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna. It is a Class II device, regulated under 21 CFR 866.3183 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QLX, 2 in the last five years, from 2 different applicants. The average 510(k) review took 221 days (median 258); 258 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna |
| Device class | Class II |
| Regulation | 21 CFR 866.3183 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QLX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 88 |
| 2022 | 1 | 317 |
| 2025 | 1 | 258 |
Compare with all 510(k) review times · Search every QLX clearance
Top QLX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 2 | 2025-07-28 |
| Roche Molecular Systems, Inc. | 1 | 2021-01-29 |
Most recent QLX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243489 | Abbott Molecular, Inc. | Alinity m EBV (09N43-095) | 2025-07-28 | 258 |
| K212778 | Abbott Molecular, Inc. | 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) | 2022-07-15 | 317 |
| K203220 | Roche Molecular Systems, Inc. | cobas BKV | 2021-01-29 | 88 |
Recalls for QLX devices
openFDA lists no recalls for product code QLX.
Frequently asked questions
What is FDA product code QLX?
QLX is the FDA product code for nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna. It is a Class II device, regulated under 21 CFR 866.3183 and reviewed by the Microbiology panel.
What device class is QLX?
Class II, regulation 21 CFR 866.3183. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLX?
Across 3 cleared submissions the average was 221 days from receipt to decision (median 258).
Which companies have the most QLX clearances?
Abbott Molecular, Inc. (2); Roche Molecular Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QLX
- Run a recall and safety report across every QLX manufacturer
- Watch product code QLX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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