Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QQX — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
203 daysmedian FDA review time
320 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025-02-13 | 105 | 0 |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/680 | Roche Molecular Systems, Inc. | 2025-02-11 | 319 | 0 |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® | 2025-01-15 | 180 | 0 |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV | Abbott Molecular | 2024-12-06 | 186 | 0 |
| K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | 2024-07-10 | 264 | 0 |
| K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023-10-13 | 234 | 0 |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/ | Roche Molecular Systems, Inc. | 2023-06-01 | 27 | 0 |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 | Roche Molecular Systems, Inc. | 2022-10-22 | 320 | 0 |
| K212147 | Simplexa COVID-19 Direct | Diasorin Molecular, LLC | 2022-09-13 | 431 | 0 |
| K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022-07-25 | 67 | 0 |
| K211079 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2021-11-01 | 203 | 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