DiaSorin Liaison Treponema Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061247 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 DiaSorin Liaison Treponema Assay is an enzyme linked immunoabsorption assay for the qualitative determination of antibodies to Treponema pallidum in human serum and plasma samples, including post-mortem specimens. It is a one-step chemiluminescence immunoassay (CLIA) performed on the LIAISON® Analyzer, detecting total antibodies (IgG/IgM) against Treponema pallidum using recombinant T. pallidum antigens coated on magnetic particles linked to an isoluminol derivative tracer.
The assay is supplied as a kit for in vitro diagnostic use and is intended for use in clinical laboratory settings. It has received FDA 510(k) clearance under k-number K061247 and is classified as a Class II device under regulation number 866.3830 with product code LIP. The device is not described as sterile, single-use, reusable, or MRI safe in the provided data, and no storage conditions are specified.
Frequently asked questions
What is the DiaSorin Liaison Treponema Assay used for?
The DiaSorin Liaison Treponema Assay is used for the qualitative determination of antibodies to Treponema pallidum in human serum and plasma samples, including post-mortem specimens, to aid in the detection of syphilis infection.
How is the DiaSorin Liaison Treponema Assay performed?
The assay is performed as a one-step chemiluminescence immunoassay (CLIA) on the LIAISON® Analyzer, using recombinant T. pallidum antigens coated on magnetic particles linked to an isoluminol derivative tracer to detect total IgG/IgM antibodies.
What sample types are compatible with the DiaSorin Liaison Treponema Assay?
The assay is compatible with human serum and plasma samples, including post-mortem specimens, for in vitro diagnostic use in clinical laboratory settings.
Is the DiaSorin Liaison Treponema Assay supplied as a kit?
Yes, the DiaSorin Liaison Treponema Assay is supplied as a kit for in vitro diagnostic use, containing all necessary reagents for performing the test on the LIAISON® Analyzer system.
What regulatory clearance does the DiaSorin Liaison Treponema Assay have?
The DiaSorin Liaison Treponema Assay has received FDA 510(k) clearance under k-number K061247 and is classified as a Class II device under regulation number 866.3830 with product code LIP.
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: LIAISON® Treponema Screen | Immunodiagnostics | Diasorin, LIAISON® Treponema Screen | Immunodiagnostics | Diasorin, DIASORIN LIAISON TREPONEMA ASSAY (K061247) — FDA 510 (k) | Innolitics, Infectious Diseases Diagnostics | Immunodiagnostics | Diasorin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061247 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K061247 24 fields · synced Sep 22, 2026