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.
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| 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 |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Emd Chemicals, Inc. — 3 clearances
- American Monitor Corp. — 2 clearances
- Diagnostic Chemicals , Ltd. — 2 clearances
- Harleco — 2 clearances
