Product code CGX
- Device name
- Alkaline Picrate, Colorimetry, Creatinine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1225
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026-01-09 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025-11-26 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-19 |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022-03-22 |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016-11-15 |
| K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | 2014-01-27 |
| K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 |
| K123586 | EASYRA CREATININE REAGENT | Medica Corporation | 2013-05-15 |
| K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | HORIBA ABX SAS | 2012-04-30 |
| K083809 | CREATININE | Abbott Laboratories | 2009-04-07 |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | Horiba Abx | 2007-11-30 |
| K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 |
| K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 |
| K071283 | SYNCHRON SYSTEMS CREATININE REAGENT | Beckman Coulter, Inc. | 2007-06-01 |
| K061193 | CREATININE | Abbott Laboratories, Inc. | 2006-06-23 |
| K060935 | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | Beckman Coulter, Inc. | 2006-04-28 |
| K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | Arkray, Inc. | 2005-04-06 |
| K040976 | GENCHEM CREATININE REAGENT | Genchem, Inc. | 2004-12-27 |
| K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | Diamond Diagnostics, Inc. | 2004-01-30 |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-02-14 |
| K002156 | APPRAISE URINE MICROALBUMIN COLLECTION KIT | Osborn Group, Inc. | 2000-12-19 |
| K003247 | CREATININE | Jas Diagnostics, Inc. | 2000-12-14 |
| K001769 | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT | Ortho-Clinical Diagnostics | 2000-06-21 |
| K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 | Diagnostic Chemicals , Ltd. | 2000-02-18 |
| K991109 | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 | A.P. Total Care, Inc. | 1999-05-25 |
| K983937 | DUAL VIAL CREATININE REAGENT | Intersect Systems, Inc. | 1999-01-06 |
| K981799 | CREA | Abbott Laboratories | 1998-07-22 |
| K981240 | CREATININE (CREA) | Abbott Laboratories | 1998-05-29 |
| K973993 | RANDOX CREATININE | Randox Laboratories, Ltd. | 1998-03-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414611075 | Atellica CH Crea3 | Siemens Healthcare Diagnostics Inc. | 2026-05-08 |
| 00630414653259 | Atellica CH Crea3 | Siemens Healthcare Diagnostics Inc. | 2026-05-08 |
| 10673486014044 | Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480 | TECO DIAGNOSTICS | 2026-04-30 |
| 10673486014037 | Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240 | TECO DIAGNOSTICS | 2026-04-30 |
| 00380740159535 | ARCHITECT | ABBOTT IRELAND | 2024-08-15 |
| 00380740159528 | Alinity | ABBOTT IRELAND | 2024-08-15 |
| 00850053916106 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-09 |
| 10673486001556 | Teco Diagnostics Creatinine Reagent Set (Direct Endpoint Procedure) | TECO DIAGNOSTICS | 2023-11-06 |
| 10673486001549 | Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480 | TECO DIAGNOSTICS | 2023-11-06 |
| 10673486001518 | Teco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent Set | TECO DIAGNOSTICS | 2023-11-06 |
| 00811727015808 | Pointe Creatinine for BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 00630414551364 | DCA Vantage® Analyzer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| EABA40000341 | Piccolo MetLyte Plus CRP | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000331 | Piccolo Kidney Check | ABAXIS, INC. | 2016-09-23 |
| EABA40000311 | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000271 | Piccolo Renal Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000241 | Piccolo Basic Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000231 | Piccolo MetLyte 8 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000061 | Piccolo General Chemistry 6 | ABAXIS, INC. | 2016-09-23 |
| 04015630922284 | Creatinine Jaff Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630918355 | Creatinine Jaff method | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630910762 | Creatinine Jaff method | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630910427 | Creatinine Jaff method | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630926824 | Creatinine Jaff Gen2 compensated) | Roche Diagnostics GmbH | 2016-09-20 |
| 03610230005736 | ABX PENTRA CREATININE 120 CP | HORIBA ABX SAS | 2016-08-16 |