LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Microbiology · 21 CFR 866.3780 · Class 2
Overview
| Product Code | LGD |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Regulation | 21 CFR 866.3780 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 106)
Showing 20 most recent of 106 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242022 | Access Toxo IgG | Beckman Coulter, Inc. | Mar 28, 2025 | SESE |
| K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | Oct 11, 2024 | SESE |
| K233932 | Alinity i Toxo IgM | Abbott Laboratories | Aug 30, 2024 | SESE |
| K210596 | ARCHITECT Toxo IgG | Abbott Laboratories | May 19, 2022 | SESE |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics | Jun 23, 2017 | SESE |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Siemens Healthcare Diagnostics, Inc. | Dec 22, 2015 | SESE |
| K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | DiaSorin, Inc. | Aug 28, 2013 | SESE |
| K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | DiaSorin, Inc. | Aug 9, 2013 | SESE |
| K101946 | VIDAS TOXO IGG AVIDITY | bioMerieux, Inc. | May 18, 2011 | SESE |
| K102681 | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) | Siemens Healthcare Diagnostics, Inc. | May 4, 2011 | SESE |
| K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | Bio-Rad Laboratories | Jul 1, 2009 | SESE |
| K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG | Roche Diagnostics Corp. | Jun 9, 2008 | SESE |
| K080869 | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC | Beckman Coulter, Inc. | May 23, 2008 | SESE |
| K052499 | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS | Diasorin S.P.A | Feb 8, 2006 | SESE |
| K032162 | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY | Beckman Coulter, Inc. | Aug 8, 2003 | SESE |
| K031506 | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY | Beckman Coulter, Inc. | Jun 2, 2003 | SESE |
| K013839 | BIO-RAD PLATELIA TOXO IGG TMB | Bio-Rad | Sep 30, 2002 | SESE |
| K013837 | BIO-RAD PLATELIA TOXO IGM TMB | Bio-Rad | Sep 30, 2002 | SESE |
| K012075 | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 | Diagnostic Products Corp. | Jan 10, 2002 | SESE |
| K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY | Bayer Diagnostics Corp. | Dec 27, 2001 | SESE |
Top Applicants
- Abbott Laboratories — 12 clearances
- Beckman Coulter, Inc. — 7 clearances
- Gull Laboratories, Inc. — 6 clearances
- Labsystems, Inc. — 5 clearances
- Diamedix Corp. — 4 clearances
