ENA IGG BeadChip Test System, Array Imaging System, Models 800-00025, AIS 400
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043067 FDA 510(k)
- FDA Product Code
- LLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ENA IGG BeadChip Test System is an Extractable Antinuclear Antibody, Antigen, and Control device, classified as a Class II diagnostic substrate. It combines a BeadChip microarray platform with an automated array imaging system (AIS 400) to detect and quantify extractable nuclear antigens (ENA) and immunoglobulin G (IgG) antibodies. The system leverages bead-based immunoassay technology to enable high-throughput, multiplexed analysis for immunology applications, including the detection of autoimmune markers.
The AIS 400 is supplied as a reusable imaging and analysis system, comprising a microscope, automated stage, focus motor, light source, CCD camera, and proprietary software (BioArray Solution Reader, Client Merger). It is intended for use in clinical or research laboratories with immunology expertise, where sterility is maintained through single-use BeadChip assays. The device operates under FDA 510(k) clearance (K043067) and adheres to regulatory requirements for immunology diagnostics (regulation number 866.5100). No MRI safety or size-specific storage instructions are specified.
Frequently asked questions
What types of antibodies and antigens does the ENA IGG BeadChip Test System detect, and how does it differ from traditional methods?
The ENA IGG BeadChip Test System detects and quantifies extractable nuclear antigens (ENA) and immunoglobulin G (IgG) antibodies using bead-based immunoassay technology on a microarray platform. Unlike traditional methods, it enables high-throughput, multiplexed analysis, allowing simultaneous testing for multiple autoimmune markers in a single assay. This streamlines workflows in clinical or research immunology labs by reducing the need for separate tests and improving efficiency.
Is the AIS 400 imaging system reusable, and if so, how is sterility maintained during use?
Yes, the AIS 400 imaging system is reusable and designed for long-term use in laboratories. Sterility is maintained through the use of single-use BeadChip assays, which are discarded after each procedure. The system itself is not sterile but operates under controlled conditions where the disposable components ensure contamination prevention during testing.
What models are available for the ENA IGG BeadChip Test System, and how do they differ?
The system is available in two primary models: 800-00025 (BeadChip assays) and AIS 400 (automated imaging system). The 800-00025 refers to the disposable BeadChip assays used for testing, while the AIS 400 is the reusable imaging and analysis system, combining a microscope, automated stage, camera, and proprietary software for reading and interpreting results. The BeadChip assays are single-use, whereas the AIS 400 is designed for repeated use in clinical or research settings.
Are there any special storage requirements for the ENA IGG BeadChip Test System components?
The AIS 400 imaging system does not have specific size or MRI-related storage restrictions mentioned in the documentation. However, since it is an electronic and optical device, it should be stored in a clean, dry environment protected from extreme temperatures, humidity, and physical damage. The single-use BeadChip assays (model 800-00025) should be stored according to the manufacturer’s instructions provided with each batch, typically in a cool, dry place until use.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for users?
The ENA IGG BeadChip Test System received FDA 510(k) clearance (K043067) under the traditional review pathway, determined to be substantially equivalent to a predicate device. This means the device meets FDA standards for safety and effectiveness as an Extractable Antinuclear Antibody, Antigen, and Control diagnostic substrate, classified as Class II. Users can rely on this clearance as evidence of regulatory compliance for immunology diagnostics, though they should always follow the manufacturer’s instructions and local laboratory protocols.
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: Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025 ..., Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025 ..., 510 (k) K043067 — ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM ..., HaRi · BioArray Solutions Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043067 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioarray Solutions Ltd
- FDA Applicant
- Bioarray Solutions, Ltd.
Sources (1)
- FDA 510(k) K043067 24 fields · synced Sep 19, 2026