JIL · Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Clinical Chemistry · 21 CFR 862.1340 · Class 2
Overview
| Product Code | JIL |
|---|---|
| Device Name | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | Apr 13, 2023 | SESE |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | May 7, 2019 | SESE |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | Jul 18, 2018 | SESE |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | May 25, 2018 | SESE |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | May 23, 2018 | SESE |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | Feb 16, 2018 | SESE |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | May 12, 2017 | SESE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | Oct 7, 2016 | SESE |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | Jul 22, 2016 | SESE |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | Jul 24, 2015 | SESE |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | May 29, 2014 | SESE |
| K120124 | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | Mar 6, 2012 | SESE |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Teco Diagnostics | Feb 4, 2011 | SESE |
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | Siemens Healthcare Diagnostics | Oct 9, 2009 | SESE |
| K061846 | COMBI SCAN100 | Analyticon Biotechnologies AG | Apr 6, 2007 | SESE |
| K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | Apr 6, 2007 | SESE |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | Mar 1, 2007 | SESE |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | Dec 28, 2006 | SESE |
| K061742 | URYXXON RELAX URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | Sep 6, 2006 | SESE |
| K060280 | 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
