Aptus Automated MPO ELISA Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984516 FDA 510(k)
- FDA Product Code
- MOB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aptus Automated MPO ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative detection of IgG antibodies to myeloperoxidase (MPO) in human serum. It functions as an automated diagnostic tool within the broader category of test systems for antineutrophil cytoplasmic antibodies (ANCA), aiding in the identification of elevated antibody levels associated with autoimmune vasculitic disorders. The device leverages ELISA technology to provide measurable results, supporting clinical assessments in immunology.
This system is supplied as a traditionally cleared medical device under FDA 510(k) clearance (K984516) and falls under Class II regulatory classification, with a primary application in immunology. It operates as an automated or manual aid, requiring no additional context beyond its intended use for serum analysis. The device is not described as single-use or reusable in the provided data, nor are MRI safety or sterility specifications mentioned. Distribution and regulatory compliance are managed by Zeus Scientific, Inc., with no explicit storage or handling instructions detailed beyond standard laboratory protocols.
Frequently asked questions
What is the Aptus Automated MPO ELISA Test System used for?
The Aptus Automated MPO ELISA Test System is designed for the semi-quantitative detection of IgG antibodies to myeloperoxidase (MPO) in human serum. It helps identify elevated antibody levels linked to autoimmune vasculitic disorders, supporting clinical assessments in immunology. By measuring these antibodies, clinicians can better diagnose conditions such as vasculitis, where MPO-ANCA (antineutrophil cytoplasmic antibodies) are commonly associated.
How is the Aptus Automated MPO ELISA Test System supplied and operated?
The system is supplied as a traditionally cleared medical device under FDA 510(k) clearance (K984516) and is intended for use in laboratory settings. It operates as an automated or manual aid for serum analysis, meaning it can be used with or without automation depending on the workflow of the laboratory. The device does not specify single-use or reusable components in the provided data, so standard laboratory protocols for handling and cleaning reusable parts would apply.
Is sterility or single-use specified for the Aptus Automated MPO ELISA Test System?
The provided data does not explicitly state whether the Aptus Automated MPO ELISA Test System or its components are single-use or reusable, nor does it mention sterility specifications. Laboratories should follow standard practices for handling and processing reagents and consumables to ensure accuracy and safety, particularly when dealing with diagnostic assays.
What regulatory classification and clearance does the Aptus Automated MPO ELISA Test System hold?
The Aptus Automated MPO ELISA Test System is classified as a Class II medical device under FDA regulations and holds a traditional 510(k) clearance (K984516). It was reviewed by the FDA’s Immunology (IM) Advisory Committee and is substantially equivalent to a predicate device, as indicated by the decision code SESE. This clearance allows it to be marketed for its intended use in immunology labs for detecting MPO antibodies.
Are there specific storage instructions for the Aptus Automated MPO ELISA Test System?
The provided data does not include explicit storage instructions for the Aptus Automated MPO ELISA Test System. However, as with most diagnostic test systems, it is recommended to store the device and its consumables according to standard laboratory protocols. This typically includes maintaining appropriate temperature conditions, protecting from contamination, and following manufacturer guidelines for reagents to ensure optimal performance and accuracy of results.
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 Mpo Elisa Test System. an ..., The Aptus (automated) Application Of The Mpo Elisa Test System. An ..., PDF K984516 the Aptus (Automated) Application of The Mpo Elisa Test System ..., 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 | K984516 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K984516 24 fields · synced Oct 1, 2026