Product Code: LFR FDA class 2 21 CFR 862.1345

Glucose Dehydrogenase, Glucose

Clinical Chemistry

A glucose dehydrogenase-based glucose test is a clinical chemistry laboratory device that uses the glucose dehydrogenase enzyme reaction to measure glucose concentrations in blood or other biological specimens, used in the diagnosis and monitoring of diabetes and hypoglycemia. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LFR and is regulated under 21 CFR 862.1345 within the Clinical Chemistry specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: LFR
Device Class: FDA class 2
Regulation Number: 862.1345
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K152328	FreeStyle InsuLinx Blood Glucose Monotioring System	Sep 17, 2015	Substantially Equivalent	Abott Laboratories
K142089	ACCU-CHEK AVIVA EXPERT SYSTEM	Dec 17, 2014	Substantially Equivalent	Roche Diagnostics Corporation
K133537	EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM	Apr 28, 2014	Substantially Equivalent	Eps Bio Technology Corp.
K131727	CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM	Feb 28, 2014	Substantially Equivalent	Ceragem Medisys, Inc.
K131366	ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM	Oct 11, 2013	Substantially Equivalent	Roche Diagnostics Operations, Inc.
K122688	NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR	Apr 04, 2013	Substantially Equivalent	Nova Biomedical Corporation
K121433	GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS	Feb 14, 2013	Substantially Equivalent	Hmd Biomedical, Inc.
K122435	NOVA ONE BLOOD GLUCOSE MONITOR	Dec 20, 2012	Substantially Equivalent	Nova Biomedical Corporation
K113314	PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM	Nov 09, 2012	Substantially Equivalent	Hmd Biomedical, Inc.
K121224	GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM	Sep 19, 2012	Substantially Equivalent	Taidoc Technology Corporation
K113307	GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM	Jul 27, 2012	Substantially Equivalent	Hmd Biomedical, Inc.
K121190	CONTOUR NEXT BLOOD GLUCOSE METER	Jul 26, 2012	Substantially Equivalent	Bayer Healthcare, LLC
K120042	TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM	May 22, 2012	Substantially Equivalent	Taidoc Technology Corporation
K121207	EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM	May 18, 2012	Substantially Equivalent	Eps Bio Technology Corp.
K113768	U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM	Apr 12, 2012	Substantially Equivalent	Taidoc Technology Corporation
K113243	EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM	Mar 28, 2012	Substantially Equivalent	Eps Bio Technology Corp.
K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	Mar 28, 2012	Substantially Equivalent	Bayer Healthcare
K110587	CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)	Mar 28, 2012	Substantially Equivalent	Bayer Healthcare, LLC
K111268	CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	Mar 06, 2012	Substantially Equivalent	Bayer Healthcare
K111874	FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS	Feb 16, 2012	Substantially Equivalent	Abbott Laboratories
K112901	EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM	Dec 23, 2011	Substantially Equivalent	Eps Bio Technology Corp.
K101299	ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM	Sep 21, 2011	Substantially Equivalent	Roche Diagnostics
K112272	EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM	Sep 07, 2011	Substantially Equivalent	Eps Bio Technology Corp.
K110637	ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM	Sep 07, 2011	Substantially Equivalent	Cilag GmbH International
K092688	FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM	Jul 06, 2011	Substantially Equivalent	Taidoc Technology Corporation
K101037	EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017	May 23, 2011	Substantially Equivalent	Eps Bio Technology Corp.
K083223	RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01	Apr 16, 2009	Substantially Equivalent	Abbott Diabetes Care, Inc.
K070984	THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS	Nov 01, 2007	Substantially Equivalent	Abbott Diabetes Care, Inc.
K060765	HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712	Sep 06, 2006	Substantially Equivalent	Hemocue AB
K051592	MODIFICATION TO ACCU-CHEK GO SYSTEM	Sep 02, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K050872	ACCU-CHEK INTEGRA SYSTEM	May 02, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K043474	ACCU-CHEK AVIVA SYSTEM	Apr 27, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K041230	CLINICAL LABORATORY ANALYZING SYSTEM	May 20, 2004	Substantially Equivalent	Hemocue, Inc.
K040796	ACCU-CHEK GO SYSTEM	Apr 22, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K032076	SENOVA(R) BLOOD GLUCOSE MONITOR	Sep 30, 2003	Substantially Equivalent	Chdiagnostics, LLC
K031755	ACCU-CHEK COMPACT TEST STRIP	Jul 03, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K022941	MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING	Oct 28, 2002	Substantially Equivalent	Abbott Laboratories
K021960	PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY	Aug 16, 2002	Substantially Equivalent	Abbott Laboratories
K004010	ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS	Apr 26, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003846	ACCU-CHEK INFORM METER	Mar 19, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010362	ACCU-CHEK COMFORT CURVE TEST STRIP	Mar 07, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K000582	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001	Dec 05, 2000	Substantially Equivalent	Abbott Diabetes Care, Inc.
K001993	SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS	Nov 13, 2000	Substantially Equivalent	Abbott Laboratories
K994433	CONNECT DATA MANAGEMENT SYSTEM	May 05, 2000	Substantially Equivalent	Abbott Diabetes Care, Inc.
K000364	ACCU-CHEK COMPLETE METER	Feb 23, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K992684	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM	Jan 14, 2000	Substantially Equivalent	Abbott Diabetes Care, Inc.
K993829	ACCU-CHEK SIMPLICITY SYSTEM	Dec 09, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K983047	ACCU-CHEK HQ SYSTEM	Feb 05, 1999	Substantially Equivalent	Boehringer Mannheim Corp.
K982089	ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS	Sep 03, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982002	ACCU-CHEK COMFORT CURVE TEST STRIP	Sep 02, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982079	ACCU-CHECK VOICEMATE	Aug 28, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K980731	ACCU-CHEK COMFORT CURVE TEST STRIPS	May 22, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K973662	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	Dec 15, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K972876	GLUCOTREND BASIC SYSTEM	Oct 09, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K962415	HEMOCUE B-GLCOSE SYSTEM	Oct 15, 1996	Substantially Equivalent	Hemocue, Inc.
K961311	HEMOCUE B-GLUCOSE SYSTEM	Aug 23, 1996	Substantially Equivalent	Hemocue, Inc.
K954833	ACCU-CHEK ADVANTAGE TEST STRIPS	Feb 15, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K951750	GLUCOSE TEST ITEM NUMBER 97375/94	Sep 06, 1995	Substantially Equivalent	Emd Chemicals, Inc.
K951887	ADVANTAGE TEST STRIPS	Aug 24, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K870708	GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM	Feb 02, 1988	Substantially Equivalent	Kyoto Daiichi Kagaku Co., Ltd.
K874708	EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008	Dec 18, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860726	ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID	Apr 21, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K855080	EMDS GLUCOSE TEST PACK ITEM 67656/95	Feb 11, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K821867	ULTRACHEM GLUC-DH	Jul 06, 1982	Substantially Equivalent	Harleco Diagnostics
K821469	ULTRACHEM GLUC-DH, #65048	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821463	ULTRACHEM GLUC-DH, #65048	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K813427	ULTRACHEM GLUC-DH	Dec 31, 1981	Substantially Equivalent	Harleco
K813042	ULTRACHEM GLUC-DH SET, ITEM #65048	Nov 10, 1981	Substantially Equivalent	Harleco
K811202	ULTRACHEM GLUC-DH, ITEM NO. 65048	May 27, 1981	Substantially Equivalent	Harleco
K791213	GLUCOSE (GDH) REAGENT	Aug 10, 1979	Substantially Equivalent	Gilford Diagnostics
K791110	KINETIC DETERMINATION OF UV GLUCOSE	Aug 03, 1979	Substantially Equivalent	The Dow Chemical Co.
K781783	BLOOD SUGAR	Dec 04, 1978	Substantially Equivalent	Gilford Diagnostics
K771102	UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS	Nov 22, 1977	Substantially Equivalent	The Dow Chemical Co.