Copalis Treponemal Antigen Total Antibody Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992552 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 Copalis Treponemal Antigen Total Antibody Assay is an enzyme linked immunoabsorption assay for the qualitative detection of total antibodies to Treponema pallidum antigens in human serum. It uses coupled particle light scattering technology in a microparticle agglutination-based immunoassay. The assay is used for the detection of antibodies indicative of current or prior infection with Treponema pallidum.
The Copalis Treponemal Antigen Total Antibody Assay is supplied for use with the Copalis I Immunoassay System. It is a microbiology device, classified as a class 2 device, with the product code LIP and regulation number 866.3830. The device has been cleared by the FDA under the traditional 510(k) clearance type, with the k number K992552.
Frequently asked questions
What is the Copalis Treponemal Antigen Total Antibody Assay used for?
The Copalis Treponemal Antigen Total Antibody Assay is used for the qualitative detection of total antibodies to Treponema pallidum antigens in human serum, indicating current or prior infection with Treponema pallidum.
How is the Copalis Treponemal Antigen Total Antibody Assay supplied?
The Copalis Treponemal Antigen Total Antibody Assay is supplied for use with the Copalis I Immunoassay System.
What type of device is the Copalis Treponemal Antigen Total Antibody Assay?
The Copalis Treponemal Antigen Total Antibody Assay is a microbiology device, classified as a class 2 device, with the product code LIP and regulation number 866.3830.
Is the Copalis Treponemal Antigen Total Antibody Assay cleared by the FDA?
Yes, the Copalis Treponemal Antigen Total Antibody Assay has been cleared by the FDA under the traditional 510(k) clearance type, with the k number K992552.
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: COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY (K992552) — FDA 510(k ..., Copalis Treponemal Antigen Total Antibody Assay, fda.innolitics.com, DiaSorin, Inc. — FDA 510 (k) clearances & recalls · 510k Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992552 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K992552 24 fields · synced Sep 22, 2026