Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) → JFY — Enzymatic Method, Creatinine # JFY · Enzymatic Method, Creatinine _Clinical Chemistry · 21 CFR 862.1225 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY ## Overview - **Product Code:** JFY - **Device Name:** Enzymatic Method, Creatinine - **Regulation:** [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K252619.md) | QSCHECK UISACR | Qstag, Inc. | Feb 20, 2026 | SESE | | [K212223](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K212223.md) | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | Nov 24, 2021 | SESE | | [K193649](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K193649.md) | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | May 10, 2021 | SESE | | [K182384](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K182384.md) | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | Jul 26, 2019 | SESE | | [K183555](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K183555.md) | GEM Premier ChemSTAT | Instrumentation Laboratory CO | Feb 16, 2019 | SESE | | [K182038](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K182038.md) | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | Dec 10, 2018 | SESE | | [K182063](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K182063.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K161527.md) | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | Jul 21, 2017 | SESE | | [K152835](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K152835.md) | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | Mar 7, 2016 | SESE | | [K142391](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K142391.md) | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | Dec 22, 2014 | SESE | | [K132399](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K132399.md) | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Elitechgroup | Jan 3, 2014 | SESE | | [K103376](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K103376.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K110137.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K093458.md) | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | Dec 4, 2009 | SESE | | [K091742](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K091742.md) | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | Aug 14, 2009 | SESE | | [K090330](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K090330.md) | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | Siemens Healthcare Diagnostics, Inc. | May 22, 2009 | SESE | | [K080073](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K080073.md) | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | Jun 30, 2008 | SESE | | [K073634](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K073634.md) | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | Jun 19, 2008 | SESE | | [K072409](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K072409.md) | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | Feb 12, 2008 | SESE | | [K073055](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY/K073055.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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