CGX · Alkaline Picrate, Colorimetry, Creatinine
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | CGX |
|---|---|
| Device Name | Alkaline Picrate, Colorimetry, Creatinine |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 159)
Showing 20 most recent of 159 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Jan 9, 2026 | SESE |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | Nov 26, 2025 | SESE |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | Dec 4, 2024 | SESE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 19, 2024 | SESE |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | Mar 22, 2022 | SESE |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | Nov 15, 2016 | SESE |
| K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | Jan 27, 2014 | SESE |
| K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | Jan 24, 2014 | SESE |
| K123586 | EASYRA CREATININE REAGENT | Medica Corporation | May 15, 2013 | SESE |
| K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | HORIBA ABX SAS | Apr 30, 2012 | SESE |
| K083809 | CREATININE | Abbott Laboratories | Apr 7, 2009 | SESE |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | Horiba Abx | Nov 30, 2007 | SESE |
| K071283 | SYNCHRON SYSTEMS CREATININE REAGENT | Beckman Coulter, Inc. | Jun 1, 2007 | SESE |
| K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | Jun 1, 2007 | SESE |
| K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | Jun 1, 2007 | SESE |
| K061193 | CREATININE | Abbott Laboratories, Inc. | Jun 23, 2006 | SESE |
| K060935 | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | Beckman Coulter, Inc. | Apr 28, 2006 | SESE |
| K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | Arkray, Inc. | Apr 6, 2005 | SESE |
| K040976 | GENCHEM CREATININE REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE |
| K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | Diamond Diagnostics, Inc. | Jan 30, 2004 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Harleco — 8 clearances
- Abbott Laboratories — 7 clearances
- Olympus Corp. — 6 clearances
- Beckman Coulter, Inc. — 4 clearances
