Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Roche Diagnostics — Predicate Candidate Screening
183 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
338 days90th percentile
183clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2026-06-12 | 322 | 0 |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026-04-13 | 265 | 0 |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026-04-02 | 87 | 0 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integra | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE ind | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-12-17 | 16 | 0 |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025-10-24 | 28 | 0 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | 2025-10-08 | 90 | 0 |
| K242505 | Elecsys Cortisol III | Roche Diagnostics | 2025-07-17 | 329 | 0 |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025-06-10 | 89 | 0 |
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | 2025-02-07 | 261 | 0 |
| K233060 | Elecsys Folate III | Roche Diagnostics | 2024-06-17 | 266 | 0 |
| K220272 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2024-04-26 | 816 | 0 |
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 2024-03-22 | 266 | 0 |
| K221890 | Elecsys Tg II | Roche Diagnostics | 2023-09-30 | 458 | 0 |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023-09-15 | 382 | 0 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2023-07-21 | 228 | 0 |
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics | 2023-06-05 | 27 | 0 |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023-04-07 | 414 | 0 |
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | 2023-03-30 | 69 | 0 |
| K221693 | Elecsys Anti-HCV II (08837031190) | Roche Diagnostics | 2023-01-04 | 208 | 0 |
| K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | 2022-12-23 | 189 | 0 |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) | Roche Diagnostics | 2022-12-07 | 166 | 0 |
| K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022-10-12 | 197 | 0 |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022-10-12 | 195 | 0 |
| K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022-10-12 | 195 | 0 |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indir | Roche Diagnostics | 2022-09-16 | 241 | 0 |
| K220176 | Elecsys AFP | Roche Diagnostics | 2022-09-15 | 237 | 0 |
| K203757 | Elecsys AMH | Roche Diagnostics | 2022-06-10 | 534 | 0 |
| K211685 | Elecsys Testosterone II | Roche Diagnostics | 2022-05-06 | 338 | 0 |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2022-03-31 | 399 | 0 |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | 2021-09-21 | 477 | 0 |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021-09-01 | 159 | 0 |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | 2021-08-18 | 289 | 0 |
| K211302 | Elecsys Syphilis | Roche Diagnostics | 2021-07-20 | 82 | 0 |
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | 2020-11-06 | 224 | 0 |
| K192815 | Elecsys BRAHMS PCT | Roche Diagnostics | 2020-03-09 | 160 | 0 |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020-02-27 | 90 | 1 |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, co | Roche Diagnostics | 2019-08-16 | 31 | 1 |
| K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019-08-13 | 172 | 0 |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019-05-07 | 147 | 0 |
| K190773 | Elecsys TSH | Roche Diagnostics | 2019-04-16 | 21 | 0 |
| K173857 | Elecsys Tacrolimus | Roche Diagnostics | 2018-11-06 | 321 | 0 |
| K181233 | Elecsys FT4 III | Roche Diagnostics | 2018-09-18 | 132 | 0 |
| K173927 | Elecsys BRAHMS PCT | Roche Diagnostics | 2018-07-06 | 192 | 0 |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-06-22 | 16 | 0 |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018-04-19 | 35 | 1 |
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