Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diagnostic Systems, Inc. — Predicate Candidate Screening
296 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
156 days90th percentile
296clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | Roche Diagnostic Systems, Inc. | 1999-05-03 | 194 | 0 |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | Roche Diagnostic Systems, Inc. | 1999-02-11 | 113 | 0 |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | 1999-02-10 | 112 | 0 |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 | 63 | 0 |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 | 63 | 0 |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K983388 | ONTRAK TESTCUP-ER | Roche Diagnostic Systems, Inc. | 1998-11-18 | 54 | 0 |
| K983174 | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZOD | Roche Diagnostic Systems, Inc. | 1998-11-18 | 69 | 0 |
| K983387 | ONTRAK TESTCUP AND TESTSTIK CONTROLS | Roche Diagnostic Systems, Inc. | 1998-10-09 | 14 | 0 |
| K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR L | Roche Diagnostic Systems, Inc. | 1998-10-01 | 50 | 0 |
| K982382 | COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1998-09-28 | 82 | 1 |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT | Roche Diagnostic Systems, Inc. | 1998-08-26 | 86 | 0 |
| K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABU | Roche Diagnostic Systems, Inc. | 1998-08-18 | 27 | 0 |
| K982087 | ROCHE CRP T CONTROL N | Roche Diagnostic Systems, Inc. | 1998-08-18 | 64 | 0 |
| K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE | Roche Diagnostic Systems, Inc. | 1998-06-05 | 80 | 0 |
| K981585 | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) | Roche Diagnostic Systems, Inc. | 1998-05-28 | 24 | 0 |
| K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) | Roche Diagnostic Systems, Inc. | 1998-05-28 | 24 | 0 |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEG | Roche Diagnostic Systems, Inc. | 1998-05-21 | 156 | 0 |
| K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE O | Roche Diagnostic Systems, Inc. | 1998-04-24 | 121 | 0 |
| K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | Roche Diagnostic Systems, Inc. | 1997-12-18 | 107 | 0 |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | 1997-11-21 | 74 | 0 |
| K973075 | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAIN | Roche Diagnostic Systems, Inc. | 1997-10-09 | 52 | 0 |
| K972891 | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS A | Roche Diagnostic Systems, Inc. | 1997-10-01 | 57 | 0 |
| K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1997-08-12 | 57 | 1 |
| K972721 | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P | Roche Diagnostic Systems, Inc. | 1997-08-06 | 16 | 0 |
| K972214 | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATH | Roche Diagnostic Systems, Inc. | 1997-06-24 | 12 | 0 |
| K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIREC | Roche Diagnostic Systems, Inc. | 1997-06-16 | 24 | 0 |
| K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | Roche Diagnostic Systems, Inc. | 1997-02-04 | 75 | 0 |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1997-01-13 | 68 | 2 |
| K964355 | ONTRAK TESTCUP 5 (MODIFICATION) | Roche Diagnostic Systems, Inc. | 1996-12-13 | 42 | 0 |
| K964422 | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL | Roche Diagnostic Systems, Inc. | 1996-11-25 | 20 | 0 |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1996-10-31 | 71 | 2 |
| K963627 | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MOD | Roche Diagnostic Systems, Inc. | 1996-10-24 | 43 | 0 |
| K962411 | ONTRAK TESTCUP AMPHETAMINES | Roche Diagnostic Systems, Inc. | 1996-10-07 | 108 | 0 |
| K961674 | ROCHE UNIMATE FRUCTOSAMINE REAGENT | Roche Diagnostic Systems, Inc. | 1996-09-27 | 149 | 0 |
| K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM | Roche Diagnostic Systems, Inc. | 1996-08-30 | 81 | 0 |
| K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | Roche Diagnostic Systems, Inc. | 1996-08-16 | 64 | 0 |
| K961824 | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOX | Roche Diagnostic Systems, Inc. | 1996-07-23 | 74 | 0 |
| K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | Roche Diagnostic Systems, Inc. | 1996-07-11 | 69 | 0 |
| K962165 | COBAS-FP TDM CALIBRATION VERIFICATION TEST SET | Roche Diagnostic Systems, Inc. | 1996-06-26 | 22 | 0 |
| K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | Roche Diagnostic Systems, Inc. | 1996-06-21 | 67 | 0 |
| K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | Roche Diagnostic Systems, Inc. | 1996-06-13 | 48 | 0 |
| K953847 | ROCHE REAGENT FOR GLUCOSE | Roche Diagnostic Systems, Inc. | 1996-02-13 | 181 | 0 |
| K952337 | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CON | Roche Diagnostic Systems, Inc. | 1996-02-09 | 266 | 2 |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1996-01-25 | 86 | 0 |
| K954655 | ROCHE CONTROL SERUM N | Roche Diagnostic Systems, Inc. | 1995-12-21 | 72 | 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