Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Roche Diagnostics Corp. — Predicate Candidate Screening
264 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
173 days90th percentile
264clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Roche Diagnostics Corp. | 2013-03-15 | 56 | 0 |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Roche Diagnostics Corp. | 2010-10-05 | 141 | 0 |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Roche Diagnostics Corp. | 2010-09-09 | 167 | 3 |
| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Roche Diagnostics Corp. | 2010-08-27 | 120 | 0 |
| K093664 | AMPHETAMINES II ASSAY | Roche Diagnostics Corp. | 2010-07-28 | 243 | 0 |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Roche Diagnostics Corp. | 2010-06-11 | 53 | 0 |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Roche Diagnostics Corp. | 2010-04-23 | 171 | 0 |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Roche Diagnostics Corp. | 2010-03-19 | 184 | 0 |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Roche Diagnostics Corp. | 2010-03-05 | 162 | 0 |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Roche Diagnostics Corp. | 2010-03-04 | 93 | 0 |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CAL | Roche Diagnostics Corp. | 2010-02-04 | 160 | 0 |
| K083764 | AMPHETAMINES II | Roche Diagnostics Corp. | 2010-02-03 | 412 | 0 |
| K092888 | ELECSYS TOXO IGG CALCHECK 5 | Roche Diagnostics Corp. | 2009-11-10 | 50 | 0 |
| K091601 | ELECYS ANTI-CCP CALCHECK | Roche Diagnostics Corp. | 2009-09-25 | 114 | 0 |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSIN | Roche Diagnostics Corp. | 2009-06-19 | 308 | 0 |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2009-03-18 | 117 | 0 |
| K072617 | ELECSYS RUBELLA IGG IMMUNOASSAY | Roche Diagnostics Corp. | 2008-12-05 | 445 | 0 |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | 2008-07-28 | 196 | 0 |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYST | Roche Diagnostics Corp. | 2008-06-20 | 88 | 0 |
| K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTR | Roche Diagnostics Corp. | 2008-06-09 | 179 | 0 |
| K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | Roche Diagnostics Corp. | 2008-05-15 | 106 | 0 |
| K080607 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MO | Roche Diagnostics Corp. | 2008-05-12 | 69 | 0 |
| K072714 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2008-04-18 | 206 | 1 |
| K080183 | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, C | Roche Diagnostics Corp. | 2008-03-25 | 60 | 0 |
| K063684 | COBAS LITHIUM | Roche Diagnostics Corp. | 2008-03-21 | 465 | 0 |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2008-03-06 | 106 | 0 |
| K080147 | ELECSYS PROBNP II CALCHECK | Roche Diagnostics Corp. | 2008-02-27 | 36 | 0 |
| K072920 | HANDHELD BASE UNIT | Roche Diagnostics Corp. | 2008-01-31 | 108 | 0 |
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #1187780 | Roche Diagnostics Corp. | 2007-10-19 | 31 | 0 |
| K071644 | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 | Roche Diagnostics Corp. | 2007-09-12 | 89 | 0 |
| K070709 | ROCHE ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-07-13 | 121 | 0 |
| K070585 | ACCU-CHEK PERFORMA SYSTEM | Roche Diagnostics Corp. | 2007-05-25 | 85 | 2 |
| K062395 | ACCU-CHEK SMART PIX | Roche Diagnostics Corp. | 2007-05-09 | 266 | 0 |
| K070391 | ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-20 | 39 | 0 |
| K070200 | TDM CONTROL SET, MODEL CAT# 04521536 | Roche Diagnostics Corp. | 2007-03-19 | 56 | 0 |
| K062203 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-14 | 225 | 1 |
| K062379 | COBAS INTEGRA CERULOPLASMIN | Roche Diagnostics Corp. | 2007-01-31 | 169 | 0 |
| K062114 | CERULOPLASMIN, MODEL 2055953 | Roche Diagnostics Corp. | 2007-01-31 | 191 | 0 |
| K063823 | COAGUCHEK XS PT CONTROLS | Roche Diagnostics Corp. | 2007-01-29 | 34 | 0 |
| K062925 | COAGUCHEK XS SYSTEM | Roche Diagnostics Corp. | 2007-01-29 | 123 | 4 |
| K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN T | Roche Diagnostics Corp. | 2006-12-22 | 28 | 0 |
| K062972 | PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS | Roche Diagnostics Corp. | 2006-10-13 | 14 | 0 |
| K062319 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 | Roche Diagnostics Corp. | 2006-09-13 | 35 | 0 |
| K062239 | GLUCOSE HK NEW FORMULATION TEST SYSTEM | Roche Diagnostics Corp. | 2006-09-11 | 40 | 0 |
| K060773 | ONLINE TDM PROCAINAMIDE | Roche Diagnostics Corp. | 2006-08-23 | 154 | 0 |
| K060738 | TDM N-ACETYLPROCAINAMIDE | Roche Diagnostics Corp. | 2006-08-16 | 149 | 1 |
| K060620 | ACCU-CHEK AVIVA TEST STRIPS | Roche Diagnostics Corp. | 2006-08-11 | 156 | 1 |
| K053287 | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Diagnostics Corp. | 2006-08-10 | 258 | 0 |
| K053289 | COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corp. | 2006-08-10 | 258 | 0 |
| K060690 | ONLINE VALPROIC ACID | Roche Diagnostics Corp. | 2006-08-08 | 146 | 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