Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QEP — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
171 daysmedian FDA review time
521 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cob | Roche Molecular Systems, Inc. | 2026-07-08 | 111 | 0 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | 171 | 0 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | 171 | 0 |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025-10-01 | 139 | 0 |
| K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 | 179 | 0 |
| K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-17 | 357 | 0 |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-16 | 357 | 0 |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023-12-22 | 325 | 0 |
| K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023-03-07 | 386 | 0 |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023-03-03 | 210 | 1 |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 | Hologic, Inc. | 2022-06-03 | 120 | 0 |
| K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022-05-10 | 438 | 1 |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022-04-29 | 576 | 0 |
| K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation | Rheonix, Inc. | 2021-12-17 | 773 | 0 |
| K200748 | Visby Medical Sexual Health | Visby Medical | 2021-08-26 | 521 | 0 |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-01-21 | 153 | 0 |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay | Hologic, Inc. | 2020-05-17 | 46 | 0 |
| K200533 | binx io CT/NG Assay and binx io CT/NG System | Binx Health, Inc. | 2020-04-27 | 56 | 1 |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo | Hologic, Inc. | 2020-03-23 | 28 | 0 |
| K191352 | binx health io CT/NG Assay | Binx Health, Inc. | 2019-08-08 | 80 | 0 |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and | Cepheid | 2019-05-23 | 87 | 0 |
| K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2019-05-23 | 83 | 0 |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG | Roche Molecular Systems, Inc. | 2019-05-22 | 89 | 0 |
| DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019-01-23 | 145 | 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