Bioplex 2200 Syphilis Igg Kit On The Bioplex 2200 Multi-Analyte Detection System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063866 FDA 510(k)
- FDA Product Code
- LIP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3830 FDA 510(k)
- Regulation Number
- 866.3830 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BioPlex 2200 Syphilis IgG Kit is an Enzyme-Linked Immunoabsorption Assay (ELISA) for the qualitative numeric detection of IgG antibodies to Treponema pallidum in human serum. It functions as a multiplex flow immunoassay, designed to identify serological evidence of infection caused by T. pallidum when used alongside non-treponemal assays. The device leverages the BioPlex 2200 Multi-Analyte Detection System to automate and streamline testing, ensuring precise and reproducible results.
This kit is intended for use in clinical microbiology laboratories and requires human serum samples for analysis. It is supplied as a single-use reagent kit, with no regulatory indication of sterility or MRI compatibility. The system operates within Class II (Special Controls) medical devices under FDA 510(k) clearance (K063866), adhering to regulatory standards for microbiology assays. Storage and handling follow standard laboratory protocols for immunoassay reagents.
Frequently asked questions
What is the BioPlex 2200 Syphilis IgG Kit used for?
The BioPlex 2200 Syphilis IgG Kit is designed for the qualitative numeric detection of IgG antibodies to *Treponema pallidum* in human serum. It serves as a multiplex flow immunoassay to identify serological evidence of syphilis infection when used alongside non-treponemal assays. This helps clinicians confirm or rule out *T. pallidum* infection in clinical microbiology settings.
How is the kit supplied, and is it single-use?
The kit is supplied as a single-use reagent kit, meaning each kit is intended for one testing session. This ensures consistency and reduces the risk of cross-contamination, which is critical for accurate immunoassay results. The design aligns with standard laboratory practices for immunoassay reagents.
Does the kit require any special handling or storage conditions?
The kit follows standard laboratory protocols for storage and handling, typical of immunoassay reagents. While specific storage instructions are not detailed in the provided data, it is generally recommended to store the kit at the manufacturer’s recommended temperature (typically 2–8°C) and protect it from light and extreme temperatures. Always refer to the included instructions for precise guidance.
Is the BioPlex 2200 system required to use this kit?
Yes, the BioPlex 2200 Syphilis IgG Kit is specifically designed to operate on the BioPlex 2200 Multi-Analyte Detection System. This system automates and streamlines the testing process, ensuring precise, reproducible results for detecting IgG antibodies to *Treponema pallidum*. The kit is not compatible with other systems.
What regulatory pathway does this device follow?
The BioPlex 2200 Syphilis IgG Kit is classified under Class II (Special Controls) medical devices and has received FDA 510(k) clearance (K063866). This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for microbiology assays. The submission was reviewed by the Microbiology (MI) Advisory Committee.
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: BioPlex 2200 Syphilis Total & RPR - Bio-Rad, PDF BioPlex 2200 Syphilis IgG Kit - Bio-Rad, PDF BioPlex 2200 Syphilis IgG and IgM - Bio-Rad
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063866 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA 510(k) K063866 24 fields · synced Oct 5, 2026