Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Molecular Systems, Inc. — Predicate Candidate Screening
53 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
363 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | 2026-07-16 | 192 | 0 |
| 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 |
| K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | 2025-11-20 | 350 | 0 |
| K252481 | cobas CMV | Roche Molecular Systems, Inc. | 2025-11-03 | 88 | 0 |
| K252484 | cobas HCV | Roche Molecular Systems, Inc. | 2025-11-03 | 88 | 0 |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 | Roche Molecular Systems, Inc. | 2025-07-31 | 266 | 0 |
| K243863 | Opulus™ Lymphoma Precision | Roche Molecular Systems, Inc. | 2025-05-30 | 164 | 0 |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 | 175 | 0 |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-25 | 176 | 0 |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | 2025-04-11 | 165 | 0 |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/680 | Roche Molecular Systems, Inc. | 2025-02-11 | 319 | 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 |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat | Roche Molecular Systems, Inc. | 2023-12-04 | 353 | 0 |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use | Roche Molecular Systems, Inc. | 2023-07-27 | 238 | 0 |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/ | Roche Molecular Systems, Inc. | 2023-06-01 | 27 | 0 |
| K221007 | cobas HCV | Roche Molecular Systems, Inc. | 2022-11-04 | 213 | 0 |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 | Roche Molecular Systems, Inc. | 2022-10-22 | 320 | 0 |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the c | Roche Molecular Systems, Inc. | 2022-07-06 | 210 | 0 |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2021-10-20 | 77 | 0 |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2021-09-09 | 212 | 0 |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the c | Roche Molecular Systems, Inc. | 2021-02-16 | 19 | 0 |
| K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021-01-29 | 88 | 0 |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-01-21 | 153 | 0 |
| K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative | Roche Molecular Systems, Inc. | 2020-09-02 | 27 | 0 |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative | Roche Molecular Systems, Inc. | 2020-07-30 | 150 | 0 |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas L | Roche Molecular Systems, Inc. | 2020-02-10 | 28 | 0 |
| DEN190016 | cobas vivoDx MRSA | Roche Molecular Systems, Inc. | 2019-12-05 | 261 | 0 |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas L | Roche Molecular Systems, Inc. | 2019-07-24 | 27 | 0 |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG | Roche Molecular Systems, Inc. | 2019-05-22 | 89 | 0 |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018-03-21 | 90 | 0 |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018-01-12 | 109 | 0 |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat Syst | Roche Molecular Systems, Inc. | 2017-09-12 | 90 | 0 |
| K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017-02-09 | 87 | 0 |
| K150617 | cobas HSV 1 and 2 Test | Roche Molecular Systems, Inc. | 2015-06-01 | 83 | 0 |
| K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015-05-20 | 265 | 0 |
| K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | 2014-12-17 | 85 | 0 |
| K140887 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2014-05-05 | 28 | 0 |
| K132270 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2013-12-02 | 133 | 0 |
| K110923 | COBAS 4800 CT / NG TEST | Roche Molecular Systems, Inc. | 2012-01-24 | 298 | 2 |
| K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER | Roche Molecular Systems, Inc. | 2010-07-06 | 419 | 0 |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | Roche Molecular Systems, Inc. | 2005-01-10 | 14 | 1 |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | Roche Molecular Systems, Inc. | 2004-12-23 | 3 | 0 |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | Roche Molecular Systems, Inc. | 2002-02-01 | 150 | 3 |
| K974503 | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Molecular Systems, Inc. | 1999-12-01 | 733 | 1 |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1999-08-04 | 674 | 1 |
| K974342 | ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Molecular Systems, Inc. | 1999-05-28 | 556 | 0 |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1998-12-15 | 442 | 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