Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CFR — Predicate Candidate Screening
145 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
207 days90th percentile
145clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integra | Roche Diagnostics | 2026-02-12 | 111 | 0 |
| K252357 | Glucose2 | Abbott Ireland | 2025-10-24 | 87 | 0 |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indir | Roche Diagnostics | 2022-09-16 | 241 | 0 |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, co | Roche Diagnostics | 2019-08-16 | 31 | 1 |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | 2017-10-19 | 260 | 1 |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Sys | Elitechgroup | 2016-09-07 | 261 | 0 |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, | Diatron U.S., Inc. | 2016-01-14 | 226 | 0 |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Beckman Coulter, Inc. | 2014-04-17 | 356 | 0 |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, AC | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 | 207 | 0 |
| K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS | Siemens Healthcare Diagnostics, Inc. | 2012-05-15 | 70 | 0 |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE ( | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 | 94 | 0 |
| K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-03-23 | 219 | 0 |
| K113131 | LIASYS 450 | Ams | 2012-03-08 | 136 | 0 |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011-12-01 | 365 | 0 |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | HORIBA ABX SAS | 2011-11-08 | 316 | 1 |
| K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODEL | Siemens Healthcare Diagnostics | 2011-03-07 | 249 | 0 |
| K092603 | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | Roche Diagnostics | 2009-12-04 | 101 | 0 |
| K090703 | POLY-CHEM 90 GLUCOSE | Polymedco, Inc. | 2009-10-20 | 217 | 0 |
| K092506 | EASYRA GLU-H REAGENT, MODEL 10200 | Medica Corp. | 2009-09-16 | 30 | 0 |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTR | Horiba Abx | 2008-09-12 | 130 | 1 |
| K080468 | LIASYS WITH MODELS LIASYS | Ams S.R.L. Analyzer Medical System | 2008-07-25 | 155 | 0 |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991 | Wako Chemicals USA, Inc. | 2008-07-17 | 182 | 0 |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 327 | 0 |
| K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-02-01 | 193 | 1 |
| K062118 | POINTE 360 | Pointe Scientific, Inc., | 2007-07-13 | 353 | 0 |
| K061879 | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CH | Hemodiagnostica, LLC | 2006-12-15 | 165 | 0 |
| K062239 | GLUCOSE HK NEW FORMULATION TEST SYSTEM | Roche Diagnostics Corp. | 2006-09-11 | 40 | 0 |
| K061048 | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM | Roche Diagnostics Corp. | 2006-05-17 | 30 | 0 |
| K060383 | GLUCOSE | Abbott Laboratories | 2006-05-05 | 80 | 0 |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM | Beckman Coulter, Inc. | 2006-02-27 | 26 | 23 |
| K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. M | Horiba Abx | 2005-12-16 | 144 | 4 |
| K052163 | ADVIA IMS GLUCOSE ASSAY | Bayer Healthcare, LLC | 2005-10-11 | 63 | 0 |
| K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER | Thermo Electron Corporation | 2005-04-27 | 204 | 0 |
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | 72 | 0 |
| K031135 | GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) | Dade Behring, Inc. | 2003-06-02 | 54 | 0 |
| K024281 | WAKO L-TYPE GLUCOSE 2 | Wako Chemicals USA, Inc. | 2003-02-24 | 63 | 0 |
| K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 | Diagnostic Chemicals , Ltd. | 2003-01-17 | 71 | 0 |
| K020852 | POLY-CHEM GLUCOSE | Polymedco, Inc. | 2002-07-03 | 110 | 0 |
| K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | Bayer Corp. | 2001-11-20 | 151 | 0 |
| K012668 | RAICHEM GLUCOSE UV REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | 63 | 0 |
| K011900 | GLUCOSE (HEXOKINASE) | Jas Diagnostics, Inc. | 2001-07-31 | 43 | 2 |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | 2000-11-20 | 123 | 14 |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17 | Sigma Diagnostics, Inc. | 2000-08-10 | 99 | 0 |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | Elan Diagnostics | 2000-05-17 | 89 | 0 |
| K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | Teco Diagnostics | 2000-02-08 | 26 | 0 |
| K990981 | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE | A.P. Total Care, Inc. | 1999-05-25 | 63 | 0 |
| K984574 | INFINITY GLUCOSE REAGENT | Sigma Diagnostics, Inc. | 1999-02-11 | 50 | 0 |
| K980883 | N-ASSAY GLU-UL | Crestat Diagnostics, Inc. | 1998-09-03 | 178 | 0 |
| K981185 | GLU | Abbott Laboratories | 1998-05-07 | 35 | 0 |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOG | Trace America, Inc. | 1998-03-10 | 64 | 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