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/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K020486.md) | CARESIDE GGT | Careside, Inc. | Jul 1, 2002 | SESE | | [K961919](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K961919.md) | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | Jul 1, 1996 | SESE | | [K923509](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K923509.md) | GAMMA-GT | Randox Laboratories, Ltd. | Dec 3, 1992 | SESE | | [K923091](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K923091.md) | KING DIAGNOSTICS GAMMA GT REAGENT | King Diagnostics, Inc. | Sep 9, 1992 | SESE | | [K905618](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K905618.md) | GGT REAGENT | Amresco, Inc. | Feb 26, 1991 | SESE | | [K903304](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K903304.md) | ROCHE COBAS READY GGT REAGENT | Roche Diagnostic Systems, Inc. | Oct 12, 1990 | SESE | | [K901090](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K901090.md) | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | Mar 29, 1990 | SESE | | [K895984](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K895984.md) | WAKO(TM) AUTOKIT GAMMA-GT | Wako Chemicals USA, Inc. | Nov 8, 1989 | SESE | | [K881239](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K881239.md) | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | May 31, 1988 | SESE | | [K874903](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K874903.md) | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Simmler, Inc. | Feb 11, 1988 | SESE | | [K871979](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K871979.md) | GAMMA GLUTAMYLTRANSFERASE REAGENT | Intersect Systems, Inc. | Jun 11, 1987 | SESE | | [K864208](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K864208.md) | VISION (TM) GGTP | Abbott Laboratories | Nov 24, 1986 | SESE | | [K863586](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K863586.md) | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | Oct 3, 1986 | SESE | | [K861672](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K861672.md) | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE | | [K860723](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K860723.md) | G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT | Trace Scientific , Ltd. | Apr 7, 1986 | SESE | | [K860348](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K860348.md) | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | Mar 17, 1986 | SESE | | [K855186](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K855186.md) | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Technostics Intl. | Jan 14, 1986 | SESE | | [K855156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K855156.md) | GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE | | [K850788](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K850788.md) | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Mar 19, 1985 | SESE | | [K842104](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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