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 862.1340](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1340) → JIL — Method, Enzymatic, Glucose (Urinary, Non-Quantitative) # JIL · Method, Enzymatic, Glucose (Urinary, Non-Quantitative) _Clinical Chemistry · 21 CFR 862.1340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL ## Overview - **Product Code:** JIL - **Device Name:** Method, Enzymatic, Glucose (Urinary, Non-Quantitative) - **Regulation:** [21 CFR 862.1340](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1340) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 81) Showing 20 most recent of 81 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K193514](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K193514.md) | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | Apr 13, 2023 | SESE | | [K183432](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K183432.md) | cobas u 601 urinalysis test system | Roche Diagnostics | May 7, 2019 | SESE | | [K173327](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K173327.md) | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | Jul 18, 2018 | SESE | | [K180356](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K180356.md) | inui In-Home Urine Analysis Test System | Scanadu, Inc. | May 25, 2018 | SESE | | [K181024](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K181024.md) | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | May 23, 2018 | SESE | | [K171521](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K171521.md) | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | Feb 16, 2018 | SESE | | [K171083](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K171083.md) | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | May 12, 2017 | SESE | | [K160062](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K160062.md) | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | Oct 7, 2016 | SESE | | [K160372](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K160372.md) | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | Jul 22, 2016 | SESE | | [K141289](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K141289.md) | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | Jul 24, 2015 | SESE | | [K131600](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K131600.md) | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | May 29, 2014 | SESE | | [K120124](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K120124.md) | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | Mar 6, 2012 | SESE | | [K101673](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K101673.md) | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Teco Diagnostics | Feb 4, 2011 | SESE | | [K091216](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K091216.md) | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | Siemens Healthcare Diagnostics | Oct 9, 2009 | SESE | | [K061846](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K061846.md) | COMBI SCAN100 | Analyticon Biotechnologies AG | Apr 6, 2007 | SESE | | [K061812](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K061812.md) | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | Apr 6, 2007 | SESE | | [K063390](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K063390.md) | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | Mar 1, 2007 | SESE | | [K063276](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K063276.md) | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | Dec 28, 2006 | SESE | | [K061742](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K061742.md) | URYXXON RELAX URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | Sep 6, 2006 | SESE | | [K060280](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K060280.md) | ICHEM 100 URINE CHEMISTRY ANALYZER | Iris International, Inc. | Jun 13, 2006 | SESE | ## Top Applicants - Syn-Kit, Inc. — 11 clearances - Tanabe U.S.A., Inc. — 8 clearances - Teco Diagnostics — 7 clearances - Kyoto Diagnostics, Inc. — 4 clearances - Analyticon Biotechnologies AG — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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