Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIG · Predicate Candidate Screening
235 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
147 days90th percentile
235clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 | 245 | 0 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 | 255 | 0 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 | 245 | 0 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 | 59 | 0 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 | 28 | 2 |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinic | Elitechgroup | 2017-07-11 | 60 | 0 |
| K150510 | Total Bilirubin | Abbott Laboratories | 2015-04-02 | 34 | 0 |
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 | Roche Diagnostics | 2013-07-17 | 49 | 2 |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | 38 | 0 |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Medica Corp. | 2013-03-01 | 81 | 0 |
| K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | Roche Diagnostics | 2013-02-28 | 64 | 0 |
| K121985 | ARCHITECT TOTAL BILIRUBIN | Abbott Laboratories | 2013-02-01 | 210 | 0 |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINIC | Elitechgroup | 2011-10-07 | 200 | 0 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | 2011-09-01 | 132 | 0 |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAM | Instrumentation Laboratory CO | 2010-06-18 | 207 | 5 |
| K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MOD | Medica Corp. | 2009-09-04 | 64 | 0 |
| K081193 | COBAS INTEGRA 400/800 BILIRUBIN TOTAL | Roche Diagnostics | 2009-01-16 | 263 | 0 |
| K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 | 132 | 0 |
| K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGA | Medica Corp. | 2008-12-10 | 264 | 0 |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 | 199 | 0 |
| K063744 | COBAS INTEGRA C 111 | Rochdiag | 2007-01-17 | 30 | 0 |
| K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN T | Roche Diagnostics Corp. | 2006-12-22 | 28 | 0 |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nova Biomedical Corp. | 2006-11-01 | 126 | 0 |
| K061839 | DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 | Dade Behring, Inc. | 2006-08-29 | 61 | 0 |
| K061719 | DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION V | Dade Behring, Inc. | 2006-08-25 | 67 | 1 |
| K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL | Horiba Abx | 2006-08-16 | 188 | 0 |
| K060574 | TOTAL BILIRUBIN | Abbott Laboratories | 2006-05-03 | 58 | 0 |
| K060628 | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/D | Dade Behring, Inc. | 2006-04-06 | 28 | 0 |
| K050869 | MODIFICATION TO ABL800 FLEX | Radiometer Medical Aps | 2005-08-11 | 127 | 1 |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Arkray, Inc. | 2005-06-17 | 16 | 0 |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Pointe Scientific, Inc., | 2004-06-02 | 106 | 3 |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | Clinical Data, Inc. | 2004-03-18 | 8 | 0 |
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | Elan Diagnostics | 2003-09-29 | 270 | 0 |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | Elan Diagnostics | 2003-09-26 | 267 | 0 |
| K024116 | WIENER LAB. BILIRUBINA DIRECT AA | Wiener Laboratories Saic | 2003-02-12 | 61 | 0 |
| K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 | Diagnostic Chemicals , Ltd. | 2002-12-11 | 68 | 0 |
| K022962 | WIENER LAB. BILIRRUBINA TOTAL AA | Wiener Laboratories Saic | 2002-11-01 | 56 | 0 |
| K022339 | TOTAL BILIRUBIN | Abbott Laboratories | 2002-09-13 | 57 | 1 |
| K022180 | DIRECT BILIRUBIN | Abbott Laboratories | 2002-09-06 | 65 | 0 |
| K011972 | DIRECT BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-08-27 | 63 | 0 |
| K003892 | TOTAL BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-02-20 | 64 | 0 |
| K003829 | TOTAL BILIRUBIN | Jas Diagnostics, Inc. | 2001-02-12 | 63 | 0 |
| K003693 | DIRECT BILIRUBIN | Jas Diagnostics, Inc. | 2001-01-29 | 60 | 0 |
| K993867 | BAYER ADVIA IMS SYSTEM | Bayer Corp. | 2000-04-10 | 147 | 0 |
| K993771 | CARESIDE DIRECT BILIRUBIN | Careside, Inc. | 1999-12-27 | 49 | 0 |
| K991866 | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122 | A.P. Total Care, Inc. | 1999-08-02 | 62 | 0 |
| K991175 | MODIFICATION TO ALCYON DIRECT BILIRUBIN | Abbott Laboratories | 1999-05-28 | 60 | 0 |
| K983304 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Synermed Intl., Inc. | 1998-11-04 | 44 | 0 |
| K983133 | TBIL | Abbott Laboratories | 1998-09-16 | 8 | 0 |
| K972382 | UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL | Arrows Co., Ltd. | 1998-09-14 | 445 | 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