Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CGS — Predicate Candidate Screening
123 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
107 days90th percentile
123clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | 2020-08-11 | 455 | 0 |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-04-17 | 202 | 0 |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistr | Siemens Healthcare Diagnostics, Inc. | 2016-09-07 | 175 | 0 |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Randox Laboratories, Ltd. | 2013-11-21 | 330 | 0 |
| K112416 | CPK REAGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 | 79 | 0 |
| K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND D | Siemens Healthcare Diagnostics | 2009-02-27 | 95 | 0 |
| K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REA | Siemens Healthcare Diagnostics | 2008-08-29 | 71 | 0 |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | 2008-04-18 | 221 | 0 |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZE | Horiba Abx | 2007-06-12 | 272 | 0 |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Arkray, Inc. | 2006-01-31 | 224 | 0 |
| K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | Olympus America, Inc. | 2004-12-23 | 35 | 0 |
| K021332 | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIE | Wiener Laboratories Saic | 2002-07-03 | 68 | 0 |
| K013912 | CREATINE KINASE (CK-NAC) | Jas Diagnostics, Inc. | 2002-01-18 | 52 | 0 |
| K012474 | ATAC PAK CPK REAGENT KIT | Elan Holdings, Inc. | 2001-10-03 | 62 | 0 |
| K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | Olympus Diagnostica GmbH | 2000-01-20 | 38 | 0 |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS | Morax | 1999-12-29 | 188 | 0 |
| K983070 | CK | Abbott Laboratories | 1999-02-16 | 167 | 1 |
| K981218 | CREATINE KINASE (CK) | Abbott Laboratories | 1998-05-01 | 28 | 0 |
| K980900 | N-ASSAY CPK-L | Crestat Diagnostics, Inc. | 1998-03-26 | 16 | 0 |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | Diagnostic Chemicals , Ltd. | 1998-03-11 | 141 | 0 |
| K974833 | CK-NAC REAGENT | Intersect Systems, Inc. | 1998-02-13 | 51 | 0 |
| K972155 | CREATINE KINASE (CK) | Stanbio Laboratory | 1997-07-17 | 42 | 1 |
| K971566 | CREATINE KINASE-MB REAGENT SET | Horizon Diagnostics, Inc. | 1997-07-14 | 76 | 0 |
| K971396 | CK REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-29 | 44 | 0 |
| K962247 | HICHEM CK/NAC REAGENT KIT | Elan Pharma, Inc. | 1996-08-15 | 65 | 0 |
| K951223 | CK-MB (NAC-ACT) | Randox Laboratories, Ltd. | 1995-12-26 | 281 | 0 |
| K952745 | CREATINE KINASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | 56 | 0 |
| K952646 | IL TEST CK-MB | Instrumentation Laboratory CO | 1995-08-04 | 56 | 0 |
| K950177 | CK QVET | Prisma Systems | 1995-03-03 | 45 | 0 |
| K942773 | CK-MB ASSAY, CATALOGUE NUMBER 317-10 | Diagnostic Chemicals , Ltd. | 1994-08-24 | 72 | 0 |
| K935463 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Pointe Scientific, Inc., | 1994-01-11 | 60 | 0 |
| K933675 | OPUS TOTAL CK | Pb Diagnostic Systems, Inc. | 1993-09-08 | 42 | 0 |
| K931889 | CREATINE KINASE TEST | Em Diagnostic Systems, Inc. | 1993-07-27 | 103 | 0 |
| K931326 | KING DIAGNOSTICS CK REAGENT | King Diagnostics, Inc. | 1993-06-15 | 91 | 0 |
| K930932 | SYNERMED CREATINE KINASE REAGENT KIT | Synermed, Inc. | 1993-05-11 | 77 | 0 |
| K930660 | CREATINE KINASE (CK) REAGENT SET | Pointe Scientific, Inc., | 1993-03-29 | 48 | 0 |
| K924832 | OLYMPUS CREATINE KINASE REAGENT | Olympus Corp. | 1993-01-04 | 101 | 0 |
| K925801 | REP E-Z CK-30 ISOENZYME KIT | Helena Laboratories | 1992-12-28 | 42 | 0 |
| K923511 | CK-NAC ACTIVATED KIT | Randox Laboratories, Ltd. | 1992-10-15 | 92 | 0 |
| K924704 | CREATINE KINASE (CK) TEST ITEM #65411 | Em Diagnostic Systems, Inc. | 1992-10-13 | 26 | 0 |
| K922459 | OLYMPUS CREATINE KINASE REAGENT | Olympus Corp. | 1992-07-13 | 48 | 0 |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Tech Intl. Co. | 1992-01-27 | 59 | 0 |
| K914361 | CREATINE KINASE MB TEST ITEM NUMBER 5A46 | Em Diagnostic Systems, Inc. | 1991-12-13 | 73 | 0 |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Reagents Applications, Inc. | 1991-09-25 | 57 | 0 |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Reagents Applications, Inc. | 1990-12-20 | 36 | 0 |
| K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 | Amresco, Inc. | 1990-12-11 | 104 | 0 |
| K903775 | CREATINE PHOSPHOKINASE | Amresco, Inc. | 1990-10-04 | 45 | 0 |
| K904102 | REFLOTRON CREATINE KINASE TEST TABS | Boehringer Mannheim Corp. | 1990-09-27 | 21 | 0 |
| K903333 | CREATINE KINASE TEST (CK) ITEM NUMBER 65411 | Em Diagnostic Systems, Inc. | 1990-08-17 | 23 | 0 |
| K902483 | CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 | Em Diagnostic Systems, Inc. | 1990-07-10 | 35 | 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