Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CGX — Predicate Candidate Screening
159 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
155 days90th percentile
159clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026-01-09 | 179 | 0 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025-11-26 | 236 | 0 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 | 89 | 0 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-19 | 881 | 0 |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022-03-22 | 399 | 0 |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Cal | Siemens Healthcare Diagnostics, Inc. | 2016-11-15 | 167 | 0 |
| K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | 2014-01-27 | 157 | 1 |
| K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 | 49 | 0 |
| K123586 | EASYRA CREATININE REAGENT | Medica Corporation | 2013-05-15 | 175 | 0 |
| K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTR | HORIBA ABX SAS | 2012-04-30 | 431 | 3 |
| K083809 | CREATININE | Abbott Laboratories | 2009-04-07 | 106 | 0 |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL | Horiba Abx | 2007-11-30 | 121 | 1 |
| K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 | 25 | 0 |
| K071283 | SYNCHRON SYSTEMS CREATININE REAGENT | Beckman Coulter, Inc. | 2007-06-01 | 25 | 0 |
| K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 | 25 | 1 |
| K061193 | CREATININE | Abbott Laboratories, Inc. | 2006-06-23 | 56 | 0 |
| K060935 | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | Beckman Coulter, Inc. | 2006-04-28 | 23 | 0 |
| K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | Arkray, Inc. | 2005-04-06 | 23 | 0 |
| K040976 | GENCHEM CREATININE REAGENT | Genchem, Inc. | 2004-12-27 | 257 | 0 |
| K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SY | Diamond Diagnostics, Inc. | 2004-01-30 | 123 | 0 |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-02-14 | 127 | 0 |
| K002156 | APPRAISE URINE MICROALBUMIN COLLECTION KIT | Osborn Group, Inc. | 2000-12-19 | 155 | 0 |
| K003247 | CREATININE | Jas Diagnostics, Inc. | 2000-12-14 | 58 | 0 |
| K001769 | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY P | Ortho-Clinical Diagnostics | 2000-06-21 | 9 | 0 |
| K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 | Diagnostic Chemicals , Ltd. | 2000-02-18 | 42 | 0 |
| K991109 | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K983937 | DUAL VIAL CREATININE REAGENT | Intersect Systems, Inc. | 1999-01-06 | 62 | 0 |
| K981799 | CREA | Abbott Laboratories | 1998-07-22 | 62 | 1 |
| K981240 | CREATININE (CREA) | Abbott Laboratories | 1998-05-29 | 53 | 0 |
| K973993 | RANDOX CREATININE | Randox Laboratories, Ltd. | 1998-03-06 | 136 | 0 |
| K974909 | SYNERMED CREATININE REAGENT KIT | Synermed Intl., Inc. | 1998-02-24 | 55 | 0 |
| K972743 | SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREA | Sigma Diagnostics, Inc. | 1997-09-22 | 61 | 0 |
| K971908 | CREA OR CREATININE | Carolina Liquid Chemistries Corp. | 1997-06-17 | 25 | 0 |
| K970087 | CR PERFECT | Chimera Research & Chemical, Inc. | 1997-03-06 | 55 | 0 |
| K963534 | SIGMA DIAGNOSTICS CREATININE REAGENT KIT | Sigma Diagnostics, Inc. | 1996-09-30 | 26 | 0 |
| K955938 | CREATININE REAGENT | Derma Media Lab., Inc. | 1996-03-12 | 82 | 0 |
| K954266 | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY | Solarcare Technologies Corp,Inc. | 1995-10-13 | 31 | 0 |
| K951595 | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1995-09-08 | 155 | 5 |
| K950142 | CR PERFECT | Chimera Research & Chemical, Inc. | 1995-05-25 | 132 | 0 |
| K945655 | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (I | Miles, Inc. | 1995-01-05 | 49 | 0 |
| K943005 | CREATININE QVET | Prisma Systems | 1994-11-22 | 152 | 0 |
| K943924 | CREATININE-PO REAGENT KIT | Synermed, Inc. | 1994-09-20 | 39 | 0 |
| K941837 | ROCHE REAGENT FOR CREATININE | Roche Diagnostic Systems, Inc. | 1994-08-26 | 135 | 0 |
| K934071 | KODAK EKTACHEM DT SLIDES (URCR) | Eastman Kodak Company | 1994-03-21 | 213 | 1 |
| K934587 | CREATININE-S ASSAY | Diagnostic Chemicals , Ltd. | 1994-03-11 | 169 | 0 |
| K934361 | OLYMPUS CREATININE REAGENT | Olympus Corp. | 1993-11-16 | 69 | 1 |
| K933697 | SIGMA CRE REAGENT | Sigma Chemical Co. | 1993-10-18 | 81 | 0 |
| K931939 | OLYMPUS CREATININE REAGENT | Olympus Corp. | 1993-09-21 | 155 | 0 |
| K932160 | SYSTEMATE CREATININE TEST ITEM NUMBER 65413 | Em Diagnostic Systems, Inc. | 1993-07-09 | 66 | 0 |
| K926511 | SYNERMED SINGLE REAGENT CREATININE KIT | Synermed, Inc. | 1993-02-18 | 50 | 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