JQB · Kinetic Method, Gamma-Glutamyl Transpeptidase
Clinical Chemistry · 21 CFR 862.1360 · Class 1
Overview
| Product Code | JQB |
|---|---|
| Device Name | Kinetic 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 (52)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | Diagnostic Chemicals , Ltd. | Nov 4, 1997 | SESE |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | Oct 10, 1997 | SESE |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | Carolina Liquid Chemistries Corp. | May 6, 1997 | SESE |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | Jan 13, 1997 | SESE |
| K964916 | GAMMA-GLUTAMYL TRANSPEPTIDASE | Derma Media Lab., Inc. | Jan 10, 1997 | SESE |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | Abaxis, Inc. | Sep 9, 1996 | SESE |
| K945800 | Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 | Diagnostic Chemicals , Ltd. | Jun 9, 1995 | SESE |
| K946192 | HICHEM Y-GT REAGENT KIT | Hichem Diagnostics | May 2, 1995 | SESE |
| K942962 | GGT QVET | Prisma Systems | Dec 7, 1994 | SESE |
| K935984 | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 | Sigma Diagnostics, Inc. | Jul 20, 1994 | SESE |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | Stanbio Laboratory | Jul 14, 1994 | SESE |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE |
| K931958 | SYNERMED GGT REAGENT KIT | Synermed, Inc. | Sep 8, 1993 | SESE |
| K925337 | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT | Olympus Corp. | Jan 26, 1993 | SESE |
| K924246 | ROCHE REAGENT FOR GGT | Roche Diagnostic Systems, Inc. | Nov 18, 1992 | SESE |
| K922947 | GAMMA GULTAMYL TRANSFERASE TEST | Em Diagnostic Systems, Inc. | Sep 28, 1992 | SESE |
| K922230 | OLYMPUS GGT REAGENT | Olympus Corp. | Jun 25, 1992 | SESE |
| K914731 | TRACE GAMMA GT-SS REAGENT | Trace Scientific , Ltd. | Nov 19, 1991 | SESE |
| K913024 | ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST | Em Diagnostic Systems, Inc. | Jul 26, 1991 | SESE |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Biochemical Trade, Inc. | Jan 30, 1991 | SESE |
| K905662 | SYSTEMATE GGT (EPOS APPLICATION) #65414 | Em Diagnostic Systems, Inc. | Jan 4, 1991 | SESE |
| K905085 | RAICHEM GGT REAGENT | Reagents Applications, Inc. | Dec 20, 1990 | SESE |
| K905096 | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 | Amresco, Inc. | Nov 28, 1990 | SESE |
| K901264 | COULTER GAMMA-GT (GGT) REAGENT | Coulter Corp. | Apr 16, 1990 | SESE |
| K893765 | GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 | Em Diagnostic Systems, Inc. | Jul 20, 1989 | SESE |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | American Monitor Corp. | Mar 24, 1989 | SESE |
| K884988 | GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 | Em Diagnostic Systems, Inc. | Jan 13, 1989 | SESE |
| K881626 | GAMMA-GLUTAMYL TRANSFERASE | Tech-Co, Inc. | May 27, 1988 | SESE |
| K881311 | BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Biotrol, USA, Inc. | Apr 28, 1988 | SESE |
| K873378 | GAMMA GLUTAMYLTRANSFERASE | Catachem, Inc. | Sep 8, 1987 | SESE |
| K873135 | UNIFAST GAMMA-GT | Sclavo, Inc. | Sep 4, 1987 | SESE |
| K872322 | EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 | Em Diagnostic Systems, Inc. | Jul 27, 1987 | SESE |
| K872320 | EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 | Em Diagnostic Systems, Inc. | Jul 27, 1987 | SESE |
| K860640 | EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 | Em Diagnostic Systems, Inc. | Apr 9, 1986 | SESE |
| K851999 | G-GT REAGENT | Alpkem Corp. | Jun 10, 1985 | SESE |
| K850319 | Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT | Sigma Diagnostics, Inc. | Feb 12, 1985 | SESE |
| K844720 | GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED | Data Medical Associates, Inc. | Dec 12, 1984 | SESE |
| K843268 | SYSTEMATE 2GT - 67207 | Em Diagnostic Systems, Inc. | Sep 13, 1984 | SESE |
| K834054 | DART GAMMA-GT REAGENT SYSTEM | Coulter Electronics, Inc. | Feb 4, 1984 | SESE |
| K833029 | FLOW-PAC GGT REAGENT SET | American Research Products Co. | Dec 29, 1983 | SESE |
| K833001 | PARAMAX & GLUTAMYTRANSFERASE REAGENT | American Dade | Oct 14, 1983 | SESE |
| K830308 | ULTRA ZYME PLUS GAMMA GT #65055 & 56 | Emd Chemicals, Inc. | Feb 28, 1983 | SESE |
| K830246 | CAST SHOE, CAST BOOT | Warm & Form, Orthopedic Materials | Feb 18, 1983 | SESE |
| K830240 | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 | Emd Chemicals, Inc. | Feb 18, 1983 | SESE |
| K823883 | ULTRAZYME PLUS GAMMA-GT, #64959/65032 | Emd Chemicals, Inc. | Jan 28, 1983 | SESE |
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Harleco | Feb 12, 1982 | SESE |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Harleco | Nov 10, 1981 | SESE |
| K812296 | GAMMA GLUTAMY TRANSPEPTIDASE | Pointe Scientific, Inc., | Aug 31, 1981 | SESE |
| K810434 | GAMMA-GT REAGENT SYSTEM | American Monitor Corp. | Feb 26, 1981 | SESE |
| K800769 | Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST | Sclavo, Inc. | Apr 24, 1980 | SESE |
| K780071 | GAMA-GPT REAGENT SET | Medical Analysis Systems, Inc. | Feb 14, 1978 | SESE |
| K761090 | DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE | Technicon Instruments Corp. | Dec 2, 1976 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Emd Chemicals, Inc. — 3 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- Sclavo, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
