Product Code: JPZ FDA class 1 21 CFR 862.1360

Colorimetric Method, Gamma-Glutamyl Transpeptidase

Clinical Chemistry

The Colorimetric Method, Gamma-Glutamyl Transpeptidase test is a clinical chemistry diagnostic reagent used to measure gamma-glutamyl transpeptidase (GGT) activity in serum by a colorimetric reaction, providing an enzymatic marker used in the evaluation of hepatic and biliary disease, as well as monitoring of alcohol use. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket submission. It carries product code JPZ and is regulated under 21 CFR 862.1360, within the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

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

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 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K020486	CARESIDE GGT	Jul 01, 2002	Substantially Equivalent	Careside, Inc.
K961919	DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE	Jul 01, 1996	Substantially Equivalent	Data Medical Associates, Inc.
K923509	GAMMA-GT	Dec 03, 1992	Substantially Equivalent	Randox Laboratories, Ltd.
K923091	KING DIAGNOSTICS GAMMA GT REAGENT	Sep 09, 1992	Substantially Equivalent	King Diagnostics, Inc.
K905618	GGT REAGENT	Feb 26, 1991	Substantially Equivalent	Amresco, Inc.
K903304	ROCHE COBAS READY GGT REAGENT	Oct 12, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K901090	ELITECH GAMMA GT TEST KIT	Mar 29, 1990	Substantially Equivalent	Elite Technology, Inc.
K895984	WAKO(TM) AUTOKIT GAMMA-GT	Nov 08, 1989	Substantially Equivalent	Wako Chemicals USA, Inc.
K881239	GAMMA GLUTAMYL TRANSFERASE REAGENT SET	May 31, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K874903	MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)	Feb 11, 1988	Substantially Equivalent	Simmler, Inc.
K871979	GAMMA GLUTAMYLTRANSFERASE REAGENT	Jun 11, 1987	Substantially Equivalent	Intersect Systems, Inc.
K864208	VISION (TM) GGTP	Nov 24, 1986	Substantially Equivalent	Abbott Laboratories
K863586	GAMMA GLUTAMYL TRANSFERASE PROCEDURE	Oct 03, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861672	GAMMA GLUTAMYL TRANSFERASE PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K860723	G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT	Apr 07, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K860348	GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET	Mar 17, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855186	GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K855156	GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K850788	GLUTAMYLTRANSFERASE ASSAY KIT	Mar 19, 1985	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K842104	TOYO JOZO G-GTP TEST	Aug 10, 1984	Substantially Equivalent	Advocacy International, Ltd.
K831639	WAKO R-GTP C-TEST	Jul 18, 1983	Substantially Equivalent	Wako Chemicals USA, Inc.
K823090	RAICHEM & GT REAGENT	Nov 22, 1982	Substantially Equivalent	Reagents Applications, Inc.
K822149	GILCHEM Y-GT REAGENT	Aug 12, 1982	Substantially Equivalent	Gilford Diagnostics
K821871	ULTRAZYME PLUS 2GT	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K821468	ULTRAZYME PLUS-GT, #64959 & 65032	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K803089	GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)	Jan 02, 1981	Substantially Equivalent	Environmental Chemical Specialties
K790812	COULTER ACCU-ZYME IIY-GT REAGENT KIT	Jun 28, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K781533	SMA/GGT	Oct 03, 1978	Substantially Equivalent	Technicon Instruments Corp.
K780099	ULTRAZYME PLUS GT	Mar 09, 1978	Substantially Equivalent	Harleco
K760711	REAGENT SYSTEM (NO. SC 135)	Nov 30, 1976	Substantially Equivalent	Sigma Chemical Co.
K760366	REAGENT, Y-GT MAX-PACK	Nov 01, 1976	Substantially Equivalent	Calbiochem
K760346	ASSAY FOR GAMMA GLUTAMYLTRANSFERASE	Oct 27, 1976	Substantially Equivalent	Princeton Biomedix
K760025	ULTRAZYME GT	Aug 26, 1976	Substantially Equivalent	Harleco