LJK · Antisera, If, Toxoplasma Gondii
Microbiology · 21 CFR 866.3780 · Class 2
Overview
| Product Code | LJK |
|---|---|
| Device Name | Antisera, If, 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | Dec 11, 1997 | SESE |
| K911771 | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 1, 1991 | SESE |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Microbiological Research Corp. | Feb 2, 1987 | SESE |
| K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | Widran Urological Group, Ltd. | May 2, 1986 | SESE |
| K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT | Bionetic Laboratory Products | Sep 26, 1983 | SESE |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Immulok, Inc. | Oct 27, 1982 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bionetic Laboratory Products — 1 clearance
- Boston Biomedica, Inc. — 1 clearance
- Immulok, Inc. — 1 clearance
- Microbiological Research Corp. — 1 clearance
