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) → JQB — Kinetic Method, Gamma-Glutamyl Transpeptidase # JQB · Kinetic 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/JQB ## Overview - **Product Code:** JQB - **Device Name:** Kinetic 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 52) Showing 20 most recent of 52 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K974000](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K974000.md) | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 | Diagnostic Chemicals , Ltd. | Nov 4, 1997 | SESE | | [K973157](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K973157.md) | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | Oct 10, 1997 | SESE | | [K971466](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K971466.md) | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | Carolina Liquid Chemistries Corp. | May 6, 1997 | SESE | | [K964457](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K964457.md) | ROCHE COBAS IBTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | Jan 13, 1997 | SESE | | [K964916](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K964916.md) | GAMMA-GLUTAMYL TRANSPEPTIDASE | Derma Media Lab., Inc. | Jan 10, 1997 | SESE | | [K955770](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K955770.md) | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | Abaxis, Inc. | Sep 9, 1996 | SESE | | [K945800](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K945800.md) | Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 | Diagnostic Chemicals , Ltd. | Jun 9, 1995 | SESE | | [K946192](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K946192.md) | HICHEM Y-GT REAGENT KIT | Hichem Diagnostics | May 2, 1995 | SESE | | [K942962](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K942962.md) | GGT QVET | Prisma Systems | Dec 7, 1994 | SESE | | [K935984](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K935984.md) | GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 | Sigma Diagnostics, Inc. | Jul 20, 1994 | SESE | | [K941315](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K941315.md) | STANBIO Y-GT (LIQUICOLOR) TEST SET | Stanbio Laboratory | Jul 14, 1994 | SESE | | [K935177](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K935177.md) | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE | | [K931958](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K931958.md) | SYNERMED GGT REAGENT KIT | Synermed, Inc. | Sep 8, 1993 | SESE | | [K925337](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K925337.md) | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT | Olympus Corp. | Jan 26, 1993 | SESE | | [K924246](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K924246.md) | ROCHE REAGENT FOR GGT | Roche Diagnostic Systems, Inc. | Nov 18, 1992 | SESE | | [K922947](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K922947.md) | GAMMA GULTAMYL TRANSFERASE TEST | Em Diagnostic Systems, Inc. | Sep 28, 1992 | SESE | | [K922230](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K922230.md) | OLYMPUS GGT REAGENT | Olympus Corp. | Jun 25, 1992 | SESE | | [K914731](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K914731.md) | TRACE GAMMA GT-SS REAGENT | Trace Scientific , Ltd. | Nov 19, 1991 | SESE | | [K913024](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K913024.md) | ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST | Em Diagnostic Systems, Inc. | Jul 26, 1991 | SESE | | [K905649](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB/K905649.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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