Identifiers
- 510(k) Number
- K993291 FDA 510(k)
- FDA Product Code
- LFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3510 FDA 510(k)
- Regulation Number
- 866.3510 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Copalis Rubella IgM is an Enzyme Linked Immunoabsorbent Assay (ELISA) for the qualitative detection of IgM antibodies to rubella virus. It employs Coupled Particle Light Scattering (Copalis) technology in a microparticle aggregation-based immunoassay, enabling sensitive and specific identification of rubella IgM in human serum or plasma collected with EDTA, heparin, or sodium citrate.
This device is intended for in vitro diagnostic use within microbiology laboratories. Supplied as a single-use assay, it requires manual pre-dilution of samples in provided Sample Diluent to remove interfering IgG and IdA antibodies. The assay operates on the Copalis I Immunoassay System and is classified under FDA regulation 866.3510, with clearance under 510(k) number K993291. No MRI safety or sterility specifications are noted in the data.
Frequently asked questions
What is the primary purpose of the Copalis Rubella IgM assay, and how does it differ from other rubella tests?
The Copalis Rubella IgM assay is designed for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma, helping confirm recent or primary rubella infections. Unlike other tests, it uses Coupled Particle Light Scattering (Copalis) technology, which enhances sensitivity and specificity by measuring microparticle aggregation in an immunoassay format. This distinguishes it from traditional ELISA methods, as it avoids the need for colorimetric endpoint readings and instead relies on light scattering for detection.
Is this assay suitable for use with all types of blood collection tubes, and what pre-processing steps are required?
The Copalis Rubella IgM assay is compatible with serum or plasma collected using EDTA, heparin, or sodium citrate tubes. However, manual pre-dilution of samples in the provided Sample Diluent is mandatory before testing. This step removes interfering IgG antibodies and IdA antibodies, ensuring accurate detection of IgM antibodies specific to rubella virus.
How is the Copalis Rubella IgM assay supplied, and is it intended for single-use or repeated testing?
The assay is supplied as a single-use kit, meaning each test requires a new set of reagents. It is designed for in vitro diagnostic use within microbiology laboratories and operates exclusively on the Copalis I Immunoassay System, which is not interchangeable with other platforms. This ensures consistency in results and compliance with the assay’s intended workflow.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinical laboratories?
The Copalis Rubella IgM assay received FDA clearance under a 510(k) submission (K993291) through the Traditional 510(k) pathway, with a Substantially Equivalent (SESE) determination by the Microbiology (MI) Advisory Committee. This means the device was compared to a legally marketed predicate and deemed to have the same intended use and technological characteristics, ensuring it meets FDA standards for safety and effectiveness in microbiology laboratory settings for rubella IgM detection.
Are there any special storage requirements for the Copalis Rubella IgM assay, and how should unused components be handled?
The provided data does not specify sterility or MRI safety requirements, but standard in vitro diagnostic assay storage guidelines should apply. Unused components should be stored according to the manufacturer’s instructions (likely refrigerated or at room temperature, as is typical for ELISA reagents) to maintain stability. Since it is a single-use assay, any unused reagents or sample diluent should be discarded after the expiration date or following the manufacturer’s disposal protocols to prevent contamination or degradation.
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 RUBELLA IGM (K993291) — FDA 510 (k) | Innolitics, COPALIS RUBELLA IGM 510 (k) K993291 - FDA.report, PDF K993291 - Copalis Rubella Igm, fda.innolitics.com, Rubella Virus 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 | K993291 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K993291 24 fields · synced Sep 19, 2026