Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QLX — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025-07-28 | 258 | 0 |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CT | Abbott Molecular, Inc. | 2022-07-15 | 317 | 0 |
| K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021-01-29 | 88 | 0 |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative | Roche Molecular Systems, Inc. | 2020-07-30 | 150 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda