JFY · Enzymatic Method, Creatinine
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | JFY |
|---|---|
| Device Name | Enzymatic Method, 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 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252619 | QSCHECK UISACR | Qstag, Inc. | Feb 20, 2026 | SESE |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | Nov 24, 2021 | SESE |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | May 10, 2021 | SESE |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | Jul 26, 2019 | SESE |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | Feb 16, 2019 | SESE |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | Dec 10, 2018 | SESE |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Ortho-Clinical Diagnostics, Inc. | Oct 30, 2018 | SESE |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | Jul 21, 2017 | SESE |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | Mar 7, 2016 | SESE |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | Dec 22, 2014 | SESE |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Elitechgroup | Jan 3, 2014 | SESE |
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | Seppim S.A.S. | Nov 18, 2011 | SESE |
| K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN | HORIBA ABX SAS | Aug 10, 2011 | SESE |
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | Dec 4, 2009 | SESE |
| K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | Aug 14, 2009 | SESE |
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | Siemens Healthcare Diagnostics, Inc. | May 22, 2009 | SESE |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | Jun 30, 2008 | SESE |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | Jun 19, 2008 | SESE |
| K072409 | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | Feb 12, 2008 | SESE |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Dade Behring, Inc. | Jan 3, 2008 | SESE |
Top Applicants
- Ortho-Clinical Diagnostics, Inc. — 5 clearances
- Boehringer Mannheim Corp. — 4 clearances
- Beckman Coulter, Inc. — 2 clearances
- HORIBA ABX SAS — 2 clearances
- Roche Diagnostics Corp. — 2 clearances
