Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
FDA product code JIL · Class II (moderate risk) · 21 CFR 862.1340 · Clinical Chemistry
81510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Syn-Kit, Inc. 11
- Tanabe U.S.A., Inc. 8
- Teco Diagnostics 8
- Kyoto Diagnostics, Inc. 4
- Miles Laboratories, Inc. 3
- Analyticon Biotechnologies AG 3
- Yd Pharmaceutical Corp. 3
- Roche Diagnostics Corp. 3
- Arkray, Inc. 3
- DFI Co., Ltd. 3
- Hypoguard USA, Inc. 2
- Boehringer Mannheim Corp. 2
- Genesis Labs, Inc. 2
- Macherey-Nagel GmbH & Co. KG 2
- American Diagnostic Corp. 2
- Bioscan Instruments, Inc. 1
- Lee Import Domestic Consulting 1
- Behring Diagnostics, Inc. 1
- Polymer Technology Intl. 1
- Healthy.Io, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | Arkray, Inc. | 04/13/2023SE |
| K183432 | cobas u 601 urinalysis test systemJIL · Traditional | Roche Diagnostics | 05/07/2019SE |
| K173327 | DIP/U.S. Urine Analysis Test SystemJIL · Traditional | Healthy.Io, Ltd. | 07/18/2018SE |
| K180356 | inui In-Home Urine Analysis Test SystemJIL · Traditional | Scanadu, Inc. | 05/25/2018SE |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional | DFI Co., Ltd. | 05/23/2018SE |
| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | DFI Co., Ltd. | 02/16/2018SE |
| K171083 | iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional | Iris Diagnostics, A Division of Iris… | 05/12/2017SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | Arkray, Inc. | 10/07/2016SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | Teco Diagnostics, Inc. | 07/22/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | Teco Diagnostics | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | Teco Diagnostics | 05/29/2014SE |
| K120124 | Foresight U120 Urine AnalyzerJIL · Special | ACON Laboratories, Inc. | 03/06/2012SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | Teco Diagnostics | 02/04/2011SE |
| K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797JIL · Traditional | Siemens Healthcare Diagnostics | 10/09/2009SE |
| K061846 | Combi SCAN100JIL · Traditional | Analyticon Biotechnologies AG | 04/06/2007SE |
| K061812 | Combi Scan 500 Urine Test Strip Analyzer, Model A93005JIL · Traditional | Analyticon Biotechnologies AG | 04/06/2007SE |
| K063390 | Urine Chemistry Analyzer UR-50JIL · Traditional | Ind Diagnostic, Inc. | 03/01/2007SE |
| K063276 | Clinitek Advantus, Model 1420JIL · Traditional | Bayer Healthcare, LLC | 12/28/2006SE |
| K061742 | Uryxxon Relax Urine AnalyzerJIL · Special | Macherey-Nagel GmbH & Co. KG | 09/06/2006SE |
| K060280 | Ichem 100 Urine Chemistry AnalyzerJIL · Traditional | Iris International, Inc. | 06/13/2006SE |
| K052525 | Cybow 11 Series Reagent Strips for UrinalysisJIL · Traditional | DFI Co., Ltd. | 03/29/2006SE |
| K051034 | Uryxxon 200 Urine AnalyzerJIL · Traditional | Macherey-Nagel GmbH & Co. KG | 11/22/2005SE |
| K050801 | Uriscan Optima II Urine AnalyzerJIL · Special | Yd Diagnostics | 04/20/2005SE |
| K042641 | CHEMVIEW-10JIL · Traditional | Cenogenics Corp. | 01/07/2005SE |
| K033851 | Diascreen Reagent Strips for Urinalysis, Models D122OO (2GK), D12100 (1K), D11100 (1G)JIL · Traditional | Hypoguard USA, Inc. | 03/02/2004SE |
| K023885 | Combi-Screen, Models 10SL and 11SLJIL · Traditional | Analyticon Biotechnologies AG | 10/21/2003SE |
| K032437 | Chemstrip 5 Ob, Chemstrip 7 and Chemstrip 10 MD Test StripsJIL · Traditional | Roche Diagnostics Corp. | 10/08/2003SE |
| K022386 | Pocketchem Ua Aution Sticks 10TAJIL · Traditional | Arkray, Inc. | 09/17/2002SE |
| K020175 | Urs-Ig (Glucose Test)JIL · Traditional | Teco Diagnostics | 03/21/2002SE |
| K012397 | Urisys 2400 Urine Test StripJIL · Traditional | Roche Diagnostics Corp. | 09/26/2001SE |
| K010973 | Diascreen 50 Urine Chemistry Analyzer, Model # 1242-00; Diascreen Reagent Strip for…JIL · Traditional | Hypoguard USA, Inc. | 09/11/2001SE |
| K991927 | Medi-Test Combi 11JIL · Traditional | Macherey-Nagel-Duren | 09/17/1999SE |
| K973142 | Dbest Reagent Strip for UrinalysisJIL · Traditional | Ameritek, Inc. | 10/20/1997SE |
| K970250 | ClinistripJIL · Traditional | Teco Diagnostics | 04/08/1997SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | Tcpi, Inc. | 07/26/1996SE |
| K961375 | Dia Screen 10 Way Reagent StripsJIL · Traditional | Genesis Labs, Inc. | 06/18/1996SE |
| K953661 | First Choice Glucose Urine Test StripsJIL · Traditional | Polymer Technology Intl. | 06/14/1996SE |
| K952307 | BioscanJIL · Traditional | Biosys Laboratories, Inc. | 09/05/1995SE |
| K952971 | Dia Screen Reagent StripsJIL · Traditional | Genesis Labs, Inc. | 08/11/1995SE |
| K942648 | In Vitro Diagnostic Urine Reagent Strips SetJIL · Traditional | Teco Diagnostics | 03/24/1995SE |
| K946116 | Uristrip Reagent Strips Test for Protein, Glucose, PH and BloodJIL · Traditional | Chemtech Labs, Inc. | 03/21/1995SE |
| K940469 | Urine Reagent STRIP-3 ParametersJIL · Traditional | Teco Diagnostics | 09/09/1994SE |
| K940043 | Bioscan Reagent StripsJIL · Traditional | Bioscan Instruments, Inc. | 04/12/1994SE |
| K932368 | Uropaper Eiken 6BJIL · Traditional | Tanabe U.S.A., Inc. | 01/13/1994SE |
| K932366 | Uropaper Eiken HagJIL · Traditional | Tanabe U.S.A., Inc. | 11/26/1993SE |
| K932365 | Uropaper Eiken AGJIL · Traditional | Tanabe U.S.A., Inc. | 11/26/1993SE |
| K932369 | Uropaper Eiken 7JIL · Traditional | Tanabe U.S.A., Inc. | 11/16/1993SE |
| K932367 | Uropaper Eiken 8JIL · Traditional | Tanabe U.S.A., Inc. | 11/16/1993SE |
| K932364 | Uropaper Eiken GPJIL · Traditional | Tanabe U.S.A., Inc. | 11/16/1993SE |
| K932363 | Uropaper Eiken GKJIL · Traditional | Tanabe U.S.A., Inc. | 11/16/1993SE |
| K931897 | UropaperJIL · Traditional | Tanabe U.S.A., Inc. | 11/16/1993SE |
| K896454 | Chemstrip(R) 10 with SG Urine Test StripsJIL · Traditional | Boehringer Mannheim Corp. | 01/11/1990SE |
| K895282 | Charise Charles Reagent StripsJIL · Traditional | Lee Import Domestic Consulting | 01/10/1990SE |
| K864544 | Diabetes Risk DetectorJIL · Traditional | Pearce Clinical Laboratories, Inc. | 07/27/1987SE |
| K870500 | Major Quality Glucose and Ketones Urine TestJIL · Traditional | American Diagnostic Corp. | 03/06/1987SE |
| K861255 | Behring Rapignost Total Screen L Urine Test StripsJIL · Traditional | Behring Diagnostics, Inc. | 10/03/1986SE |
| K861733 | Additional Kyotest Urine Test Reagent StripsJIL · Traditional | Kyoto Diagnostics, Inc. | 07/25/1986SE |
| K855239 | Biotel (Tm)/ DiabetesJIL · Traditional | American Diagnostic Corp. | 06/13/1986SE |
| K843760 | Uropaper Eiken GJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843755 | Uropaper Eiken 6BJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843754 | Uropaper Eiken 7JIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K843753 | Uropaper Eiken GPJIL · Traditional | Syn-Kit, Inc. | 12/18/1984SE |
| K841714 | Kyotest 2V, Urine Test Reagent StripJIL · Traditional | Kyoto Diagnostics, Inc. | 05/31/1984SE |
| K841713 | Kyotest Ug Urine Test Reagent StripJIL · Traditional | Kyoto Diagnostics, Inc. | 05/31/1984SE |
| K834387 | Yd Strip GPH U21JIL · Traditional | Yd Pharmaceutical Corp. | 05/14/1984SE |
| K834386 | Yd Strip GP U20JIL · Traditional | Yd Pharmaceutical Corp. | 05/14/1984SE |
| K834385 | Yd Strip Glucose U19JIL · Traditional | Yd Pharmaceutical Corp. | 05/11/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | Kyoto Diagnostics, Inc. | 04/19/1984SE |
| K831600 | Diastix Reagent Strips for UrinalysisJIL · Traditional | Miles Laboratories, Inc. | 09/08/1983SE |
| K831498 | Uri-Test 3, Inlab Reagent Strips-UrinalJIL · Traditional | Laprol Scientific, Inc. | 06/22/1983SE |
| K820594 | Biostrip GJIL · Traditional | Helena Laboratories | 05/05/1982SE |
| K811816 | Uropaper Eiken UhagJIL · Traditional | Syn-Kit, Inc. | 12/08/1981SE |
| K811818 | Uropaper Eiken UagJIL · Traditional | Syn-Kit, Inc. | 07/23/1981SE |
| K811817 | Uropaper Eiken AGJIL · Traditional | Syn-Kit, Inc. | 07/15/1981SE |
| K771755 | 9-WAY Urine Test with AscorbicJIL · Traditional | Miles Laboratories, Inc. | 10/25/1977SE |
| K761310 | Mega-DiastixJIL · Traditional | Miles Laboratories, Inc. | 03/21/1977SE |
| K770271 | Chemstrip GJIL · Traditional | Boehringer Mannheim Corp. | 03/16/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0799-2026 Class II | Diabetes Test (ketones & glucose)Distribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1834-2024 Class II | Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones…The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the… | Macherey Nagel Gmbh & Co. Kg | 04/04/2024Open, Classified |
| Z-0099-2017 Class II | URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | Roche Diagnostics Operations, Inc. | 07/15/2016Terminated |
| Z-0649-2016 Class II | iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement…Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte… | Beckman Coulter Inc. | 12/08/2014Terminated |
| Z-0083-2015 Class II | External power supply adaptors that accompany Clinitek Status Power Supply Adaptor -…The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can… | Siemens Healthcare Diagnostics, Inc | 09/19/2014Terminated |
| Z-0082-2015 Class II | External power supply adaptors that accompany Clinitek Status Connect System The…The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can… | Siemens Healthcare Diagnostics, Inc | 09/19/2014Terminated |
| Z-0081-2015 Class II | External power supply adaptors that accompany Clinitek Status+ The Clinitek Status…The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can… | Siemens Healthcare Diagnostics, Inc | 09/19/2014Terminated |