Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JFY — Predicate Candidate Screening
49 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
305 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252619 | QSCHECK UISACR | Qstag, Inc. | 2026-02-20 | 185 | 0 |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 | 131 | 0 |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | 2021-05-10 | 497 | 0 |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019-07-26 | 329 | 0 |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 | 58 | 0 |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analy | Yd Diagnostics Corporation | 2018-12-10 | 133 | 0 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Prod | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 | 90 | 11 |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | 2017-07-21 | 414 | 0 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-03-07 | 160 | 0 |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagen | ACON Laboratories, Inc. | 2014-12-22 | 117 | 0 |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITRO | Elitechgroup | 2014-01-03 | 155 | 0 |
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, C | Seppim S.A.S. | 2011-11-18 | 366 | 0 |
| K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX | HORIBA ABX SAS | 2011-08-10 | 204 | 2 |
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL | Beckman Coulter, Inc. | 2009-12-04 | 28 | 0 |
| K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL | Beckman Coulter, Inc. | 2009-08-14 | 59 | 0 |
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 | 101 | 4 |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | 2008-06-30 | 171 | 0 |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | 2008-06-19 | 176 | 1 |
| K072409 | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | 2008-02-12 | 169 | 0 |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH M | Dade Behring, Inc. | 2008-01-03 | 65 | 4 |
| K070824 | CREATININE (ENZYMATIC) | Thermofisher Scientific OY | 2007-12-03 | 252 | 0 |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | Siemens Medical Solutions Diagnostics | 2007-08-03 | 141 | 4 |
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | Diagnostic Chemicals , Ltd. | 2007-06-22 | 133 | 2 |
| K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | 23 | 1 |
| K071215 | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | 23 | 0 |
| K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY | Diazyme Laboratories | 2007-04-23 | 273 | 0 |
| K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | Thermo Electron Corp. | 2007-03-23 | 305 | 0 |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATO | Wako Chemicals USA, Inc. | 2007-02-23 | 245 | 0 |
| K063591 | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 | 14 | 1 |
| K061944 | POLY-CHEM CREATININE | Polymedco, Inc. | 2006-11-03 | 116 | 0 |
| K050283 | CREATININE LIQUICOLOR | Stanbio Laboratory | 2005-06-30 | 143 | 0 |
| K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | Diametrics Medical, Inc. | 2003-06-25 | 173 | 0 |
| K024098 | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY | Roche Diagnostics Corp. | 2002-12-19 | 7 | 1 |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Bayer Corp. | 2002-07-05 | 63 | 0 |
| K012065 | WIENER LAB. CREATININA CINETICA AA | Wiener Laboratories Saic | 2001-10-10 | 100 | 0 |
| K010456 | BIOSCANNER CREATININE TEST STRIPS | Polymer Technology Systems, Inc. | 2001-06-20 | 124 | 1 |
| K003261 | CREATININE PLUS | Roche Diagnostics Corp. | 2000-11-16 | 29 | 1 |
| K001310 | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2000-05-05 | 10 | 0 |
| K984530 | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE | Metrika, Inc. | 1999-08-10 | 232 | 0 |
| K980043 | CARESIDE CREATININE | Exigent Diagnostics, Inc. | 1998-03-30 | 83 | 0 |
| K912807 | ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 | Em Diagnostic Systems, Inc. | 1991-10-31 | 128 | 0 |
| K913105 | REFLOTRON CREATININE TEST TABS | Boehringer Mannheim Corp. | 1991-08-12 | 31 | 0 |
| K903573 | REFLOTRON CREATININE TEST TABS | Boehringer Mannheim Corp. | 1990-09-07 | 31 | 0 |
| K875191 | KODAK EKTACHEM DT SLIDES (CRSC) | Eastman Kodak Company | 1988-02-24 | 69 | 0 |
| K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) | Reagents Applications, Inc. | 1987-02-12 | 52 | 0 |
| K863078 | CREATININE-E | J. D. Assoc. | 1986-09-09 | 28 | 0 |
| K854766 | CREATININE PAP | Boehringer Mannheim Corp. | 1986-01-17 | 51 | 0 |
| K841070 | CREATININE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K812095 | ENXYMATIC CREATININE TEST | Boehringer Mannheim Corp. | 1981-08-31 | 38 | 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