Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3450](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3450) → LCD — Enzyme Immunoassay, Gentamicin # LCD · Enzyme Immunoassay, Gentamicin _Clinical Toxicology · 21 CFR 862.3450 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD ## Overview - **Product Code:** LCD - **Device Name:** Enzyme Immunoassay, Gentamicin - **Regulation:** [21 CFR 862.3450](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3450) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) - **3rd-party reviewable:** yes ## Identification A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243500](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K243500.md) | ARCHITECT iGentamicin | Abbott Laboratories | Jul 9, 2025 | SESE | | [K102699](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K102699.md) | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | Abbott Laboratories | Apr 1, 2011 | SESE | | [K060709](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K060709.md) | MULTIGENT GENTAMICIN | Seradyn, Inc. | Jun 15, 2006 | SESE | | [K042479](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K042479.md) | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE | Ortho-Clinical Diagnostics, Inc. | Jan 6, 2005 | SESE | | [K020704](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K020704.md) | ROCHE ONLINE GENTAMICIN | Roche Diagnostics Corp. | Jul 12, 2002 | SESE | | [K012978](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K012978.md) | RANDOX GENTAMICIN | Randox Laboratories, Ltd. | Sep 18, 2001 | SESE | | [K012311](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K012311.md) | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) | Diagnostic Products Corp. | Aug 20, 2001 | SESE | | [K010984](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K010984.md) | EMIT 2000 GENTAMICIN PLUS ASSAY | Syva Co., Dade Behring, Inc. | Apr 20, 2001 | SESE | | [K962819](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K962819.md) | GENTAMICIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 13, 1996 | SESE | | [K962519](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K962519.md) | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | Behring Diagnostics, Inc. | Sep 4, 1996 | SESE | | [K953020](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K953020.md) | ACS GENTAMICIN | Ciba Corning Diagnostics Corp. | Aug 2, 1995 | SESE | | [K943982](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K943982.md) | IL TEST GENTAMICIN CALIBRATORS | Instrumentation Laboratory CO | Jan 25, 1995 | SESE | | [K935376](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K935376.md) | AXSYM GENTAMICIN | Abbott Mfg., Inc. | Jun 21, 1994 | SESE | | [K940376](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K940376.md) | QMS GENTAMICIN ASSAY | Seradyn, Inc. | Jun 2, 1994 | SESE | | [K913470](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K913470.md) | CEDIA(R) GENTAMICIN ASSAY | Microgenics Corp. | Sep 27, 1991 | SESE | | [K904305](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K904305.md) | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Oct 15, 1990 | SESE | | [K903743](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K903743.md) | IL GENTAMICIN ASSAY SYSTEM | Instrumentation Laboratory CO | Sep 17, 1990 | SESE | | [K900703](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K900703.md) | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | Apr 12, 1990 | SESE | | [K895484](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K895484.md) | STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. | Baxter Healthcare Corp | Oct 4, 1989 | SESE | | [K893912](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K893912.md) | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD | Technicon Instruments Corp. | Aug 21, 1989 | SESE | ## Top Applicants - Syva Co. — 8 clearances - E.I. Dupont DE Nemours & Co., Inc. — 3 clearances - Abbott Laboratories — 2 clearances - Diagnostic Products Corp. — 2 clearances - Instrumentation Laboratory CO — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD) **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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