Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1360](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1360) → JPZ — Colorimetric Method, Gamma-Glutamyl Transpeptidase

# JPZ · Colorimetric Method, Gamma-Glutamyl Transpeptidase

_Clinical Chemistry · 21 CFR 862.1360 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/JPZ

## Overview

- **Product Code:** JPZ
- **Device Name:** Colorimetric Method, Gamma-Glutamyl Transpeptidase
- **Regulation:** [21 CFR 862.1360](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1360)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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 33)

Showing 20 most recent of 33 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K020486](/device/K020486.md) | CARESIDE GGT | Careside, Inc. | Jul 1, 2002 | SESE |
| [K961919](/device/K961919.md) | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | Jul 1, 1996 | SESE |
| [K923509](/device/K923509.md) | GAMMA-GT | Randox Laboratories, Ltd. | Dec 3, 1992 | SESE |
| [K923091](/device/K923091.md) | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | Sep 9, 1992 | SESE |
| [K905618](/device/K905618.md) | GGT REAGENT | Amresco, Inc. | Feb 26, 1991 | SESE |
| [K903304](/device/K903304.md) | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | Oct 12, 1990 | SESE |
| [K901090](/device/K901090.md) | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | Mar 29, 1990 | SESE |
| [K895984](/device/K895984.md) | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | Nov 8, 1989 | SESE |
| [K881239](/device/K881239.md) | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | May 31, 1988 | SESE |
| [K874903](/device/K874903.md) | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | Feb 11, 1988 | SESE |
| [K871979](/device/K871979.md) | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | Jun 11, 1987 | SESE |
| [K864208](/device/K864208.md) | VISION (TM) GGTP | Abbott Laboratories | Nov 24, 1986 | SESE |
| [K863586](/device/K863586.md) | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | Oct 3, 1986 | SESE |
| [K861672](/device/K861672.md) | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| [K860723](/device/K860723.md) | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| [K860348](/device/K860348.md) | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | Mar 17, 1986 | SESE |
| [K855186](/device/K855186.md) | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | Jan 14, 1986 | SESE |
| [K855156](/device/K855156.md) | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| [K850788](/device/K850788.md) | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Mar 19, 1985 | SESE |
| [K842104](/device/K842104.md) | TOYO JOZO G-GTP TEST | Advocacy International, Ltd. | Aug 10, 1984 | SESE |

## Top Applicants

- Data Medical Associates, Inc. — 3 clearances
- Harleco — 2 clearances
- Technostics Intl. — 2 clearances
- Wako Chemicals USA, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/JPZ](https://fda.innolitics.com/productcode/JPZ)

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