Product Code: JQB FDA class 1 21 CFR 862.1360

Kinetic Method, Gamma-Glutamyl Transpeptidase

Clinical Chemistry

The Kinetic Method, Gamma-Glutamyl Transpeptidase test is a clinical chemistry diagnostic reagent used to measure GGT activity in serum by a kinetic (rate) reaction method, which monitors the continuous rate of substrate hydrolysis over time for precise enzyme activity determination in the evaluation of liver and biliary tract disease. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQB and is regulated under 21 CFR 862.1360, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JQB
Device Class: FDA class 1
Regulation Number: 862.1360
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974000	Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30	Nov 04, 1997	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K973157	LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET	Oct 10, 1997	Substantially Equivalent	Pointe Scientific, Inc.,
K971466	SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)	May 06, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K964457	ROCHE COBAS IBTEGRA REAGENT CASSETTES	Jan 13, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K964916	GAMMA-GLUTAMYL TRANSPEPTIDASE	Jan 10, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K955770	GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM	Sep 09, 1996	Substantially Equivalent	Abaxis, Inc.
K945800	Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05	Jun 09, 1995	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K946192	HICHEM Y-GT REAGENT KIT	May 02, 1995	Substantially Equivalent	Hichem Diagnostics
K942962	GGT QVET	Dec 07, 1994	Substantially Equivalent	Prisma Systems
K935984	GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419	Jul 20, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K941315	STANBIO Y-GT (LIQUICOLOR) TEST SET	Jul 14, 1994	Substantially Equivalent	Stanbio Laboratory
K935177	GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST	Dec 16, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K931958	SYNERMED GGT REAGENT KIT	Sep 08, 1993	Substantially Equivalent	Synermed, Inc.
K925337	OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT	Jan 26, 1993	Substantially Equivalent	Olympus Corp.
K924246	ROCHE REAGENT FOR GGT	Nov 18, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K922947	GAMMA GULTAMYL TRANSFERASE TEST	Sep 28, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K922230	OLYMPUS GGT REAGENT	Jun 25, 1992	Substantially Equivalent	Olympus Corp.
K914731	TRACE GAMMA GT-SS REAGENT	Nov 19, 1991	Substantially Equivalent	Trace Scientific , Ltd.
K913024	ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST	Jul 26, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905649	GAMMA-GLUTAMYL TRANSFERASE DETERMINATION	Jan 30, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K905662	SYSTEMATE GGT (EPOS APPLICATION) #65414	Jan 04, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905085	RAICHEM GGT REAGENT	Dec 20, 1990	Substantially Equivalent	Reagents Applications, Inc.
K905096	GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138	Nov 28, 1990	Substantially Equivalent	Amresco, Inc.
K901264	COULTER GAMMA-GT (GGT) REAGENT	Apr 16, 1990	Substantially Equivalent	Coulter Corp.
K893765	GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1	Jul 20, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890312	GAMMA-GLUTAMYLTRANSFERASE	Mar 24, 1989	Substantially Equivalent	American Monitor Corp.
K884988	GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664	Jan 13, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K881626	GAMMA-GLUTAMYL TRANSFERASE	May 27, 1988	Substantially Equivalent	Tech-Co, Inc.
K881311	BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST	Apr 28, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K873378	GAMMA GLUTAMYLTRANSFERASE	Sep 08, 1987	Substantially Equivalent	Catachem, Inc.
K873135	UNIFAST GAMMA-GT	Sep 04, 1987	Substantially Equivalent	Sclavo, Inc.
K872322	EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95	Jul 27, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K872320	EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616	Jul 27, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860640	EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93	Apr 09, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K851999	G-GT REAGENT	Jun 10, 1985	Substantially Equivalent	Alpkem Corp.
K850319	Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT	Feb 12, 1985	Substantially Equivalent	Sigma Diagnostics, Inc.
K844720	GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED	Dec 12, 1984	Substantially Equivalent	Data Medical Associates, Inc.
K843268	SYSTEMATE 2GT - 67207	Sep 13, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K834054	DART GAMMA-GT REAGENT SYSTEM	Feb 04, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K833029	FLOW-PAC GGT REAGENT SET	Dec 29, 1983	Substantially Equivalent	American Research Products Co.
K833001	PARAMAX & GLUTAMYTRANSFERASE REAGENT	Oct 14, 1983	Substantially Equivalent	American Dade
K830308	ULTRA ZYME PLUS GAMMA GT #65055 & 56	Feb 28, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K830246	CAST SHOE, CAST BOOT	Feb 18, 1983	Substantially Equivalent	Warm & Form, Orthopedic Materials
K830240	ULTRAZYME PLUS GAMMA GT-MCA #65055-65056	Feb 18, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K823883	ULTRAZYME PLUS GAMMA-GT, #64959/65032	Jan 28, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K820233	ULTRAZYME PLUS GAMMA GT(65055-65056)	Feb 12, 1982	Substantially Equivalent	Harleco
K813041	ULTRAZYME-GT, ITEM #64959 & 65032	Nov 10, 1981	Substantially Equivalent	Harleco
K812296	GAMMA GLUTAMY TRANSPEPTIDASE	Aug 31, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K810434	GAMMA-GT REAGENT SYSTEM	Feb 26, 1981	Substantially Equivalent	American Monitor Corp.
K800769	Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST	Apr 24, 1980	Substantially Equivalent	Sclavo, Inc.
K780071	GAMA-GPT REAGENT SET	Feb 14, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K761090	DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE	Dec 02, 1976	Substantially Equivalent	Technicon Instruments Corp.