Enzyme Immunoassay, Gentamicin
FDA product code LCD · Class II (moderate risk) · 21 CFR 862.3450 · Clinical Toxicology
37510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Syva Co. 8
- E.I. Dupont DE Nemours & Co., Inc. 3
- Abbott Laboratories 2
- Diagnostic Products Corp. 2
- Technicon Instruments Corp. 2
- Instrumentation Laboratory CO 2
- Seradyn, Inc. 2
- Innotron of Oregon, Inc. 1
- Randox Laboratories, Ltd. 1
- Syva Co., Dade Behring, Inc. 1
- Dade Intl., Inc. 1
- Behring Diagnostics, Inc. 1
- Ciba Corning Diagnostics Corp. 1
- Abbott Mfg., Inc. 1
- Microgenics Corp. 1
- Baxter Healthcare Corp 1
- Em Diagnostic Systems, Inc. 1
- Clinical Data, Inc. 1
- American Dade 1
- Beckman Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicinLCD · Special | Abbott Laboratories | 07/09/2025SE |
| K102699 | Architect Igentamicin Reagents; Architect Igentamicin CalibratorsLCD · Traditional | Abbott Laboratories | 04/01/2011SE |
| K060709 | Multigent GentamicinLCD · Traditional | Seradyn, Inc. | 06/15/2006SE |
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…LCD · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/06/2005SE |
| K020704 | Roche Online GentamicinLCD · Traditional | Roche Diagnostics Corp. | 07/12/2002SE |
| K012978 | Randox GentamicinLCD · Traditional | Randox Laboratories, Ltd. | 09/18/2001SE |
| K012311 | Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)LCD · Traditional | Diagnostic Products Corp. | 08/20/2001SE |
| K010984 | Emit 2000 Gentamicin Plus AssayLCD · Special | Syva Co., Dade Behring, Inc. | 04/20/2001SE |
| K962819 | Gentamicin Flex Reagent CartridgeLCD · Traditional | Dade Intl., Inc. | 09/13/1996SE |
| K962519 | Emit 2000 Gentamicin Assay and CalibratorsLCD · Traditional | Behring Diagnostics, Inc. | 09/04/1996SE |
| K953020 | Acs GentamicinLCD · Traditional | Ciba Corning Diagnostics Corp. | 08/02/1995SE |
| K943982 | Il Test Gentamicin CalibratorsLCD · Traditional | Instrumentation Laboratory CO | 01/25/1995SE |
| K935376 | Axsym GentamicinLCD · Traditional | Abbott Mfg., Inc. | 06/21/1994SE |
| K940376 | QMS Gentamicin AssayLCD · Traditional | Seradyn, Inc. | 06/02/1994SE |
| K913470 | Cedia(R) Gentamicin AssayLCD · Traditional | Microgenics Corp. | 09/27/1991SE |
| K904305 | Dupont Dimension(R) Gentamicin(Gent) MethodLCD · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/15/1990SE |
| K903743 | Il Gentamicin Assay SystemLCD · Traditional | Instrumentation Laboratory CO | 09/17/1990SE |
| K900703 | Modified Accufluor Gentamicin Reagent & CalibratorLCD · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| K895484 | Stratus(R) Gentamicin Fluorometric Enzyme Immuno.LCD · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
| K893912 | Technicon Ra Systems Gentamicin Test MethodLCD · Traditional | Technicon Instruments Corp. | 08/21/1989SE |
| K874703 | Emit Convenience Pack: Gentamicin AssayLCD · Traditional | Syva Co. | 12/18/1987SE |
| K873855 | Emit QST Gentamicin AssayLCD · Traditional | Syva Co. | 10/29/1987SE |
| K873854 | Emit Gentamicin AssayLCD · Traditional | Syva Co. | 10/28/1987SE |
| K871329 | Easy-Test Emit Gentamicin (Gent) Item No. 16640LCD · Traditional | Em Diagnostic Systems, Inc. | 05/12/1987SE |
| K862260 | Emit Chloramphenicol Assay/Bi-Level ControlsLCD · Traditional | Syva Co. | 11/03/1986SE |
| K860868 | Technicon Ra Systems/Tobramycin & GentamicinLCD · Traditional | Technicon Instruments Corp. | 04/03/1986SE |
| K860045 | Determination of GentamicinLCD · Traditional | Clinical Data, Inc. | 01/22/1986SE |
| K852672 | Aca Gentamicin Test PackLCD · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/02/1985SE |
| K850060 | Du Pont Gentamicin Assay ReagentsLCD · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/18/1985SE |
| K832445 | Stratus Gentamicin Fluorometric EnzymLCD · Traditional | American Dade | 08/31/1983SE |
| K832056 | Emit Amd Gentamicin AssayLCD · Traditional | Syva Co. | 08/08/1983SE |
| K831416 | Emit QST Tobramycin AssayLCD · Traditional | Syva Co. | 06/08/1983SE |
| K831304 | Emit QST Gentamicin AssayLCD · Traditional | Syva Co. | 06/02/1983SE |
| K823387 | Sopheia Gentamicin Eia KitLCD · Traditional | Diagnostic Products Corp. | 12/22/1982SE |
| K811692 | Gentamicin Reagent Test KitLCD · Traditional | Beckman Instruments, Inc. | 07/15/1981SE |
| K811744 | Virgo Ipa for Detection of GentamicinLCD · Traditional | Electro-Nucleonics Laboratories, Inc. | 07/10/1981SE |
| K800150 | Emit Tobramycin AssayLCD · Traditional | Syva Co. | 02/05/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2117-2020 Class II | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in…Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity… | Abbott Gmbh & Co. KG | 04/24/2020Open, Classified |
| Z-3180-2018 Class II | VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus…Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured… | bioMerieux, Inc. | 08/13/2018Terminated |
| Z-3179-2018 Class II | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus…Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured… | bioMerieux, Inc. | 08/13/2018Terminated |
| Z-2182-2018 Class II | Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme…The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the… | Siemens Healthcare Diagnostics, Inc. | 04/19/2018Terminated |
| Z-2181-2018 Class II | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot…The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the… | Siemens Healthcare Diagnostics, Inc. | 04/19/2018Terminated |
| Z-1739-2011 | Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an…False elevation of Dimension Vista(R) Gentamicin results for patients and QC when prior reagent aspirated by… | Siemens Healthcare Diagnostics, Inc. | 11/30/2010Terminated |
| Z-0972-2010 | Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | Roche Diagnostics Operations, Inc. | 10/07/2009Terminated |
| Z-0971-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | Roche Diagnostics Operations, Inc. | 10/07/2009Terminated |
| Z-0970-2010 | Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and…A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being… | Roche Diagnostics Operations, Inc. | 10/07/2009Terminated |
| Z-2437-2010 | SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX…The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low… | Beckman Coulter Inc. | 02/19/2009Terminated |
| Z-0930-2008 | Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent…Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F… | Abbott Diagnostic International, Ltd. | 10/26/2007Terminated |