JPZ · Colorimetric Method, Gamma-Glutamyl Transpeptidase
Clinical Chemistry · 21 CFR 862.1360 · Class 1
Overview
| Product Code | JPZ |
|---|---|
| Device Name | Colorimetric Method, Gamma-Glutamyl Transpeptidase |
| Regulation | 21 CFR 862.1360 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (33)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020486 | CARESIDE GGT | Careside, Inc. | Jul 1, 2002 | SESE |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | Jul 1, 1996 | SESE |
| K923509 | GAMMA-GT | Randox Laboratories, Ltd. | Dec 3, 1992 | SESE |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | Sep 9, 1992 | SESE |
| K905618 | GGT REAGENT | Amresco, Inc. | Feb 26, 1991 | SESE |
| K903304 | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | Oct 12, 1990 | SESE |
| K901090 | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | Mar 29, 1990 | SESE |
| K895984 | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | Nov 8, 1989 | SESE |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | May 31, 1988 | SESE |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | Feb 11, 1988 | SESE |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | Jun 11, 1987 | SESE |
| K864208 | VISION (TM) GGTP | Abbott Laboratories | Nov 24, 1986 | SESE |
| K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | Oct 3, 1986 | SESE |
| K861672 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| K860723 | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | Mar 17, 1986 | SESE |
| K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | Jan 14, 1986 | SESE |
| K855156 | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| K850788 | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Mar 19, 1985 | SESE |
| K842104 | TOYO JOZO G-GTP TEST | Advocacy International, Ltd. | Aug 10, 1984 | SESE |
| K831639 | WAKO R-GTP C-TEST | Wako Chemicals USA, Inc. | Jul 18, 1983 | SESE |
| K823090 | RAICHEM & GT REAGENT | Reagents Applications, Inc. | Nov 22, 1982 | SESE |
| K822149 | GILCHEM Y-GT REAGENT | Gilford Diagnostics | Aug 12, 1982 | SESE |
| K821871 | ULTRAZYME PLUS 2GT | Harleco Diagnostics | Jul 14, 1982 | SESE |
| K821468 | ULTRAZYME PLUS-GT, #64959 & 65032 | Emd Chemicals, Inc. | Jun 2, 1982 | SESE |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Environmental Chemical Specialties | Jan 2, 1981 | SESE |
| K790812 | COULTER ACCU-ZYME IIY-GT REAGENT KIT | Coulter Electronics, Inc. | Jun 28, 1979 | SESE |
| K781533 | SMA/GGT | Technicon Instruments Corp. | Oct 3, 1978 | SESE |
| K780099 | ULTRAZYME PLUS GT | Harleco | Mar 9, 1978 | SESE |
| K760711 | REAGENT SYSTEM (NO. SC 135) | Sigma Chemical Co. | Nov 30, 1976 | SESE |
| K760366 | REAGENT, Y-GT MAX-PACK | Calbiochem | Nov 1, 1976 | SESE |
| K760346 | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE | Princeton Biomedix | Oct 27, 1976 | SESE |
| K760025 | ULTRAZYME GT | Harleco | Aug 26, 1976 | SESE |
Top Applicants
- Data Medical Associates, Inc. — 3 clearances
- Wako Chemicals USA, Inc. — 2 clearances
- Technostics Intl. — 2 clearances
- Harleco — 2 clearances
- Trace Scientific , Ltd. — 1 clearance
