Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3780](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3780) → LLA — Direct Agglutination Test, Toxoplasma Gondii

# LLA · Direct Agglutination Test, Toxoplasma Gondii

_Microbiology · 21 CFR 866.3780 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA

## Overview

- **Product Code:** LLA
- **Device Name:** Direct Agglutination Test, Toxoplasma Gondii
- **Regulation:** [21 CFR 866.3780](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3780)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K913467](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA/K913467.md) | TOXOGEN | Biokit USA, Inc. | Jan 11, 1993 | SESE |
| [K890048](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA/K890048.md) | QUIK-DOT TOXOPLASMOSIS | Ampcor, Inc. | Jun 9, 1989 | SESE |
| [K850768](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA/K850768.md) | TOXOSCAN CARD TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 20, 1985 | SESE |
| [K831930](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA/K831930.md) | TOXO-SCREEN DA TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 26, 1983 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Ampcor, Inc. — 1 clearance
- Biokit USA, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLA)

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