Product Code: JIL FDA class 2 21 CFR 862.1340

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Clinical Chemistry

Enzymatic Method for Glucose (Urinary, Non-Quantitative) is a clinical chemistry test system using enzymatic reactions to detect the presence of glucose in urine on a non-quantitative basis, used for screening of diabetes mellitus and renal glycosuria. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JIL, regulated under 21 CFR 862.1340, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: JIL
Device Class: FDA class 2
Regulation Number: 862.1340
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 81 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193514	AUTION MAX AX-4060 Urinalysis System	Apr 13, 2023	Substantially Equivalent	Arkray, Inc.
K183432	cobas u 601 urinalysis test system	May 07, 2019	Substantially Equivalent	Roche Diagnostics
K173327	DIP/U.S. Urine Analysis Test System	Jul 18, 2018	Substantially Equivalent	Healthy.Io, Ltd.
K180356	inui In-Home Urine Analysis Test System	May 25, 2018	Substantially Equivalent	Scanadu, Inc.
K181024	DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips	May 23, 2018	Substantially Equivalent	DFI Co., Ltd.
K171521	DUS R-50S (Urine Chemistry system)	Feb 16, 2018	Substantially Equivalent	DFI Co., Ltd.
K171083	iChemVELOCITY Automated Urine Chemistry System	May 12, 2017	Substantially Equivalent	Iris Diagnostics, A Division of Iris International, Inc.
K160062	AUTION ELEVEN Semi-Automated Urinalysis System	Oct 07, 2016	Substantially Equivalent	Arkray, Inc.
K160372	URITEK TC-201 URINE CHEMISTRY TEST SYSTEM	Jul 22, 2016	Substantially Equivalent	Teco Diagnostics, Inc.
K141289	TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS	Jul 24, 2015	Substantially Equivalent	Teco Diagnostics
K131600	URS-2GP (GLUCOSE PROTEIN) URINE STRIPS	May 29, 2014	Substantially Equivalent	Teco Diagnostics
K120124	FORESIGHT U120 URINE ANALYZER	Mar 06, 2012	Substantially Equivalent	ACON Laboratories, Inc.
K101673	URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10	Feb 04, 2011	Substantially Equivalent	Teco Diagnostics
K091216	CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797	Oct 09, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K061846	COMBI SCAN100	Apr 06, 2007	Substantially Equivalent	Analyticon Biotechnologies AG
K061812	COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005	Apr 06, 2007	Substantially Equivalent	Analyticon Biotechnologies AG
K063390	URINE CHEMISTRY ANALYZER UR-50	Mar 01, 2007	Substantially Equivalent	Ind Diagnostic, Inc.
K063276	CLINITEK ADVANTUS, MODEL 1420	Dec 28, 2006	Substantially Equivalent	Bayer Healthcare, LLC
K061742	URYXXON RELAX URINE ANALYZER	Sep 06, 2006	Substantially Equivalent	Macherey-Nagel GmbH & Co. KG
K060280	ICHEM 100 URINE CHEMISTRY ANALYZER	Jun 13, 2006	Substantially Equivalent	Iris International, Inc.
K052525	CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS	Mar 29, 2006	Substantially Equivalent	DFI Co., Ltd.
K051034	URYXXON 200 URINE ANALYZER	Nov 22, 2005	Substantially Equivalent	Macherey-Nagel GmbH & Co. KG
K050801	URISCAN OPTIMA II URINE ANALYZER	Apr 20, 2005	Substantially Equivalent	Yd Diagnostics
K042641	CHEMVIEW-10	Jan 07, 2005	Substantially Equivalent	Cenogenics Corp.
K033851	DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)	Mar 02, 2004	Substantially Equivalent	Hypoguard USA, Inc.
K023885	COMBI-SCREEN, MODELS 10SL AND 11SL	Oct 21, 2003	Substantially Equivalent	Analyticon Biotechnologies AG
K032437	CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS	Oct 08, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K022386	POCKETCHEM UA AUTION STICKS 10TA	Sep 17, 2002	Substantially Equivalent	Arkray, Inc.
K020175	URS-IG (GLUCOSE TEST)	Mar 21, 2002	Substantially Equivalent	Teco Diagnostics
K012397	URISYS 2400 URINE TEST STRIP	Sep 26, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010973	DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000	Sep 11, 2001	Substantially Equivalent	Hypoguard USA, Inc.
K991927	MEDI-TEST COMBI 11	Sep 17, 1999	Substantially Equivalent	Macherey-Nagel-Duren
K973142	DBEST REAGENT STRIP FOR URINALYSIS	Oct 20, 1997	Substantially Equivalent	Ameritek, Inc.
K970250	CLINISTRIP	Apr 08, 1997	Substantially Equivalent	Teco Diagnostics
K954968	HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST	Jul 26, 1996	Substantially Equivalent	Tcpi, Inc.
K961375	DIA SCREEN 10 WAY REAGENT STRIPS	Jun 18, 1996	Substantially Equivalent	Genesis Labs, Inc.
K953661	FIRST CHOICE GLUCOSE URINE TEST STRIPS	Jun 14, 1996	Substantially Equivalent	Polymer Technology Intl.
K952307	BIOSCAN	Sep 05, 1995	Substantially Equivalent	Biosys Laboratories, Inc.
K952971	DIA SCREEN REAGENT STRIPS	Aug 11, 1995	Substantially Equivalent	Genesis Labs, Inc.
K942648	IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET	Mar 24, 1995	Substantially Equivalent	Teco Diagnostics
K946116	URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD	Mar 21, 1995	Substantially Equivalent	Chemtech Labs, Inc.
K940469	URINE REAGENT STRIP-3 PARAMETERS	Sep 09, 1994	Substantially Equivalent	Teco Diagnostics
K940043	BIOSCAN REAGENT STRIPS	Apr 12, 1994	Substantially Equivalent	Bioscan Instruments, Inc.
K932368	UROPAPER EIKEN 6B	Jan 13, 1994	Substantially Equivalent	Tanabe U.S.A., Inc.
K932366	UROPAPER EIKEN HAG	Nov 26, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K932365	UROPAPER EIKEN AG	Nov 26, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K932369	UROPAPER EIKEN 7	Nov 16, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K932367	UROPAPER EIKEN 8	Nov 16, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K932364	UROPAPER EIKEN GP	Nov 16, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K932363	UROPAPER EIKEN GK	Nov 16, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K931897	UROPAPER	Nov 16, 1993	Substantially Equivalent	Tanabe U.S.A., Inc.
K896454	CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS	Jan 11, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K895282	CHARISE CHARLES REAGENT STRIPS	Jan 10, 1990	Substantially Equivalent	Lee Import Domestic Consulting
K864544	DIABETES RISK DETECTOR	Jul 27, 1987	Substantially Equivalent	Pearce Clinical Laboratories, Inc.
K870500	MAJOR QUALITY GLUCOSE AND KETONES URINE TEST	Mar 06, 1987	Substantially Equivalent	American Diagnostic Corp.
K861255	BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS	Oct 03, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K861733	ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS	Jul 25, 1986	Substantially Equivalent	Kyoto Diagnostics, Inc.
K855239	BIOTEL (TM)/ DIABETES	Jun 13, 1986	Substantially Equivalent	American Diagnostic Corp.
K843760	UROPAPER EIKEN G	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843759	UROPAPER EIKEN HAG	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843758	UROPAPER EIKEN GK	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843757	UROPAPER EIKEN AG	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843756	UROPAPER EIKEN 5	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843755	UROPAPER EIKEN 6B	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843754	UROPAPER EIKEN 7	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K843753	UROPAPER EIKEN GP	Dec 18, 1984	Substantially Equivalent	Syn-Kit, Inc.
K841714	KYOTEST 2V, URINE TEST REAGENT STRIP	May 31, 1984	Substantially Equivalent	Kyoto Diagnostics, Inc.
K841713	KYOTEST UG URINE TEST REAGENT STRIP	May 31, 1984	Substantially Equivalent	Kyoto Diagnostics, Inc.
K834387	YD STRIP GPH U21	May 14, 1984	Substantially Equivalent	Yd Pharmaceutical Corp.
K834386	YD STRIP GP U20	May 14, 1984	Substantially Equivalent	Yd Pharmaceutical Corp.
K834385	YD STRIP GLUCOSE U19	May 11, 1984	Substantially Equivalent	Yd Pharmaceutical Corp.
K840829	KYOTEST UGK	Apr 19, 1984	Substantially Equivalent	Kyoto Diagnostics, Inc.
K831600	DIASTIX REAGENT STRIPS FOR URINALYSIS	Sep 08, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K831498	URI-TEST 3, INLAB REAGENT STRIPS-URINAL	Jun 22, 1983	Substantially Equivalent	Laprol Scientific, Inc.
K820594	BIOSTRIP G	May 05, 1982	Substantially Equivalent	Helena Laboratories
K811816	UROPAPER EIKEN UHAG	Dec 08, 1981	Substantially Equivalent	Syn-Kit, Inc.
K811818	UROPAPER EIKEN UAG	Jul 23, 1981	Substantially Equivalent	Syn-Kit, Inc.
K811817	UROPAPER EIKEN AG	Jul 15, 1981	Substantially Equivalent	Syn-Kit, Inc.
K771755	9-WAY URINE TEST WITH ASCORBIC	Oct 25, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K761310	MEGA-DIASTIX	Mar 21, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K770271	CHEMSTRIP G	Mar 16, 1977	Substantially Equivalent	Boehringer Mannheim Corp.