JFY · Class II · 21 CFR 862.1225

FDA Product Code JFY: Enzymatic Method, Creatinine

Leading manufacturers include Ortho-Clinical Diagnostics, Inc., Boehringer Mannheim Corp. and Roche Diagnostics Corp..

49
Total
49
Cleared
134d
Avg days
1981
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 185d recently vs 133d historically

FDA 510(k) Cleared Enzymatic Method, Creatinine Devices (Product Code JFY)

49 devices
1–24 of 49
Cleared Feb 20, 2026
QSCHECK UISACR
K252619
Qstag, Inc.
Chemistry · 185d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared May 10, 2021
Yumizen C1200 Creatinine PAP
K193649
HORIBA ABX SAS
Chemistry · 497d
Cleared Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384
Healthy.Io, Ltd.
Chemistry · 329d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183555
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Dec 10, 2018
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038
Yd Diagnostics Corporation
Chemistry · 133d
Cleared Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
K182063
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
K142391
ACON Laboratories, Inc.
Chemistry · 117d
Cleared Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742
Beckman Coulter, Inc.
Chemistry · 59d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
K090330
Siemens Healthcare Diagnostics, Inc.
Chemistry · 101d
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055
Dade Behring, Inc.
Chemistry · 65d
Cleared Jun 22, 2007
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383
Diagnostic Chemicals , Ltd.
Chemistry · 133d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
K071215
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
K071216
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105
Diazyme Laboratories
Chemistry · 273d
Cleared Feb 23, 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775
Wako Chemicals USA, Inc.
Chemistry · 245d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
K063591
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Jun 30, 2005
CREATININE LIQUICOLOR
K050283
Stanbio Laboratory
Chemistry · 143d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428
Bayer Corp.
Chemistry · 63d
Cleared Nov 16, 2000
CREATININE PLUS
K003261
Roche Diagnostics Corp.
Chemistry · 29d
Cleared May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001310
Ortho-Clinical Diagnostics, Inc.
Chemistry · 10d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807
Em Diagnostic Systems, Inc.
Chemistry · 128d

About Product Code JFY - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code JFY since 1981, with 49 receiving FDA clearance (average review time: 134 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JFY Product Code

Recent submissions under JFY have taken an average of 185 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

JFY devices are reviewed by the Chemistry panel. Browse all Chemistry devices →