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) → LCQ — Fluorescent Immunoassay Gentamicin # LCQ · Fluorescent 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/LCQ ## Overview - **Product Code:** LCQ - **Device Name:** Fluorescent 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 (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K972609](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K972609.md) | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM | Bio-Rad | Aug 6, 1997 | SESE | | [K955569](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K955569.md) | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Oxis Intl., Inc. | Feb 9, 1996 | SESE | | [K945523](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K945523.md) | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS | Roche Diagnostic Systems, Inc. | Mar 9, 1995 | SESE | | [K943550](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K943550.md) | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Nov 17, 1994 | SESE | | [K905721](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K905721.md) | OPUS GENTAMICIN | Pb Diagnostic Systems, Inc. | Feb 21, 1991 | SESE | | [K904226](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K904226.md) | 'TDXFLX ANALYZER | Abbott Laboratories | Oct 29, 1990 | SESE | | [K894523](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K894523.md) | FPR GENTAMICIN KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE | | [K852158](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K852158.md) | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA | Bioprobe Intl., Inc. | Jun 25, 1985 | SESE | | [K852013](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K852013.md) | GENTAMICIN KIT(FPIA) | Windsor Laboratories, Inc. | Jun 10, 1985 | SESE | | [K843827](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K843827.md) | COBAS REAGENTS FOR GENTAMICIN & CALIBRAT | Roche Diagnostic Systems, Inc. | Feb 1, 1985 | SESE | | [K841865](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K841865.md) | INNOFLOUR GENTAMICIN | Innotron Diagnostics | May 31, 1984 | SESE | | [K841162](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K841162.md) | IMMPULSE GENTAMICIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | May 2, 1984 | SESE | | [K820285](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K820285.md) | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY | Syva Co. | Feb 18, 1982 | SESE | | [K813539](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K813539.md) | GENTAMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Dec 31, 1981 | SESE | | [K810942](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K810942.md) | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | Apr 17, 1981 | SESE | | [K801867](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K801867.md) | DISPOSABLE MEDICATION NEBULIZER | Hospitax | Aug 20, 1980 | SESE | | [K801084](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K801084.md) | CYBREX GENTAMICIN | Abbott Laboratories | May 23, 1980 | SESE | | [K800032](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K800032.md) | FIAX TEST KIT FOR GENTAMICIN QUAN. | Intl. Diagnostic Technology | Jan 23, 1980 | SESE | | [K782025](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K782025.md) | GENTAMICIN FLUROIMMUNASSAY KIT | Technia Diagnostics , Ltd. | Jan 26, 1979 | SESE | ## Top Applicants - Abbott Laboratories — 2 clearances - Roche Diagnostic Systems, Inc. — 2 clearances - American Diagnostic Corp. — 1 clearance - Bio-Rad — 1 clearance - Bioprobe Intl., Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ) **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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