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.
Cleared Devices (81)
| 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 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | DFI Co., Ltd. | Mar 29, 2006 | SESE |
| K051034 | URYXXON 200 URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | Nov 22, 2005 | SESE |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | Yd Diagnostics | Apr 20, 2005 | SESE |
| K042641 | CHEMVIEW-10 | Cenogenics Corp. | Jan 7, 2005 | SESE |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) | Hypoguard USA, Inc. | Mar 2, 2004 | SESE |
| K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL | Analyticon Biotechnologies AG | Oct 21, 2003 | SESE |
| K032437 | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS | Roche Diagnostics Corp. | Oct 8, 2003 | SESE |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | Arkray, Inc. | Sep 17, 2002 | SESE |
| K020175 | URS-IG (GLUCOSE TEST) | Teco Diagnostics | Mar 21, 2002 | SESE |
| K012397 | URISYS 2400 URINE TEST STRIP | Roche Diagnostics Corp. | Sep 26, 2001 | SESE |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 | Hypoguard USA, Inc. | Sep 11, 2001 | SESE |
| K991927 | MEDI-TEST COMBI 11 | Macherey-Nagel-Duren | Sep 17, 1999 | SESE |
| K973142 | DBEST REAGENT STRIP FOR URINALYSIS | Ameritek, Inc. | Oct 20, 1997 | SESE |
| K970250 | CLINISTRIP | Teco Diagnostics | Apr 8, 1997 | SESE |
| K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST | Tcpi, Inc. | Jul 26, 1996 | SESE |
| K961375 | DIA SCREEN 10 WAY REAGENT STRIPS | Genesis Labs, Inc. | Jun 18, 1996 | SESE |
| K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS | Polymer Technology Intl. | Jun 14, 1996 | SESE |
| K952307 | BIOSCAN | Biosys Laboratories, Inc. | Sep 5, 1995 | SESE |
| K952971 | DIA SCREEN REAGENT STRIPS | Genesis Labs, Inc. | Aug 11, 1995 | SESE |
| K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | Teco Diagnostics | Mar 24, 1995 | SESE |
| K946116 | URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD | Chemtech Labs, Inc. | Mar 21, 1995 | SESE |
| K940469 | URINE REAGENT STRIP-3 PARAMETERS | Teco Diagnostics | Sep 9, 1994 | SESE |
| K940043 | BIOSCAN REAGENT STRIPS | Bioscan Instruments, Inc. | Apr 12, 1994 | SESE |
| K932368 | UROPAPER EIKEN 6B | Tanabe U.S.A., Inc. | Jan 13, 1994 | SESE |
| K932366 | UROPAPER EIKEN HAG | Tanabe U.S.A., Inc. | Nov 26, 1993 | SESE |
| K932365 | UROPAPER EIKEN AG | Tanabe U.S.A., Inc. | Nov 26, 1993 | SESE |
| K932369 | UROPAPER EIKEN 7 | Tanabe U.S.A., Inc. | Nov 16, 1993 | SESE |
| K932367 | UROPAPER EIKEN 8 | Tanabe U.S.A., Inc. | Nov 16, 1993 | SESE |
| K932364 | UROPAPER EIKEN GP | Tanabe U.S.A., Inc. | Nov 16, 1993 | SESE |
| K932363 | UROPAPER EIKEN GK | Tanabe U.S.A., Inc. | Nov 16, 1993 | SESE |
| K931897 | UROPAPER | Tanabe U.S.A., Inc. | Nov 16, 1993 | SESE |
| K896454 | CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS | Boehringer Mannheim Corp. | Jan 11, 1990 | SESE |
| K895282 | CHARISE CHARLES REAGENT STRIPS | Lee Import Domestic Consulting | Jan 10, 1990 | SESE |
| K864544 | DIABETES RISK DETECTOR | Pearce Clinical Laboratories, Inc. | Jul 27, 1987 | SESE |
| K870500 | MAJOR QUALITY GLUCOSE AND KETONES URINE TEST | American Diagnostic Corp. | Mar 6, 1987 | SESE |
| K861255 | BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS | Behring Diagnostics, Inc. | Oct 3, 1986 | SESE |
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | Kyoto Diagnostics, Inc. | Jul 25, 1986 | SESE |
| K855239 | BIOTEL (TM)/ DIABETES | American Diagnostic Corp. | Jun 13, 1986 | SESE |
| K843760 | UROPAPER EIKEN G | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843759 | UROPAPER EIKEN HAG | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843758 | UROPAPER EIKEN GK | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843757 | UROPAPER EIKEN AG | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843756 | UROPAPER EIKEN 5 | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843755 | UROPAPER EIKEN 6B | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843754 | UROPAPER EIKEN 7 | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K843753 | UROPAPER EIKEN GP | Syn-Kit, Inc. | Dec 18, 1984 | SESE |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | May 31, 1984 | SESE |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | May 31, 1984 | SESE |
| K834387 | YD STRIP GPH U21 | Yd Pharmaceutical Corp. | May 14, 1984 | SESE |
| K834386 | YD STRIP GP U20 | Yd Pharmaceutical Corp. | May 14, 1984 | SESE |
| K834385 | YD STRIP GLUCOSE U19 | Yd Pharmaceutical Corp. | May 11, 1984 | SESE |
| K840829 | KYOTEST UGK | Kyoto Diagnostics, Inc. | Apr 19, 1984 | SESE |
| K831600 | DIASTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | Sep 8, 1983 | SESE |
| K831498 | URI-TEST 3, INLAB REAGENT STRIPS-URINAL | Laprol Scientific, Inc. | Jun 22, 1983 | SESE |
| K820594 | BIOSTRIP G | Helena Laboratories | May 5, 1982 | SESE |
| K811816 | UROPAPER EIKEN UHAG | Syn-Kit, Inc. | Dec 8, 1981 | SESE |
| K811818 | UROPAPER EIKEN UAG | Syn-Kit, Inc. | Jul 23, 1981 | SESE |
| K811817 | UROPAPER EIKEN AG | Syn-Kit, Inc. | Jul 15, 1981 | SESE |
| K771755 | 9-WAY URINE TEST WITH ASCORBIC | Miles Laboratories, Inc. | Oct 25, 1977 | SESE |
| K761310 | MEGA-DIASTIX | Miles Laboratories, Inc. | Mar 21, 1977 | SESE |
| K770271 | CHEMSTRIP G | Boehringer Mannheim Corp. | Mar 16, 1977 | SESE |
Top Applicants
- Syn-Kit, Inc. — 11 clearances
- Tanabe U.S.A., Inc. — 8 clearances
- Teco Diagnostics — 7 clearances
- Kyoto Diagnostics, Inc. — 4 clearances
- Yd Pharmaceutical Corp. — 3 clearances
