Aptus Automated Application of the Toxoplasma IgM ELISA Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984170 FDA 510(k)
- FDA Product Code
- LGD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3780 FDA 510(k)
- Regulation Number
- 866.3780 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an Enzyme-Linked Immunosorbent Assay (ELISA) system for Toxoplasma gondii, designed for the presumptive, qualitative detection of IgM-class antibodies in human serum. It functions as an automated software module integrated with an ELISA plate reader to assess optical density data, enabling the presumptive diagnosis of acute, recent, or reactive Toxoplasma infection. The system adheres to the classification of an in vitro diagnostic device for microbiological testing, specifically within the field of immunology.
The Aptus system is supplied as a software module for automated processing of ELISA results, intended for use in clinical microbiology laboratories. It operates as a single-use application within a validated workflow, interfacing with compatible ELISA plate readers to interpret optical density measurements. Regulated under FDA 510(k) clearance (K984170), the device falls under Class II medical device classification (LGD) and is governed by 21 CFR Part 866.3780. No sterility or MRI safety considerations apply, as it is a non-invasive, software-based diagnostic tool.
Frequently asked questions
What is the Aptus Toxoplasma IgM ELISA system used for?
The Aptus system is designed as an automated software module for the Toxoplasma IgM ELISA test. It processes optical density data from ELISA plate readers to provide presumptive, qualitative detection of IgM-class antibodies in human serum. This aids in diagnosing acute, recent, or reactive Toxoplasma gondii infections by automating the interpretation of test results within a validated workflow.
How is the Aptus system supplied and how does it integrate with lab equipment?
The Aptus system is supplied exclusively as a software module, not as a physical device. It is intended for use with compatible ELISA plate readers in clinical microbiology laboratories. The software interfaces directly with these readers to analyze optical density measurements, enabling automated processing of ELISA results for Toxoplasma IgM detection.
Is the Aptus system single-use or reusable?
The Aptus system is a single-use application within its designated workflow. Each instance of the software is designed for a specific diagnostic run, ensuring data integrity and compliance with laboratory validation protocols. Reuse of the software module is not applicable or intended.
Does the Aptus system require sterility or have MRI safety concerns?
No, the Aptus system does not require sterility or have MRI safety considerations. As a software-based diagnostic tool, it is non-invasive and operates independently of physical patient interaction or exposure to magnetic fields. Its functionality relies solely on automated data processing and interpretation.
What regulatory pathway does the Aptus Toxoplasma IgM ELISA system follow?
The Aptus system is regulated under the FDA’s 510(k) clearance pathway, specifically under clearance number K984170. It is classified as a Class II medical device under the product code LGD (Laboratory General and Diagnostic) and is governed by 21 CFR Part 866.3780. The device was reviewed by the Microbiology (MI) Advisory Committee and determined to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Aptus (Automated) Application of The Toxoplasma Igm Elisa Test System, The Aptus (Automated) Application of The Toxoplasma Igm Elisa Test System, PDF K984170 - the Aptus (Automated) Application of The Toxoplasma Igm Elisa ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984170 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K984170 24 fields · synced Oct 5, 2026