Identifiers
- 510(k) Number
- K250768 FDA 510(k)
- FDA Product Code
- QVP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3983 FDA 510(k)
- Regulation Number
- 866.3983 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys Anti-SARS-CoV-2 is a qualitative immunoassay for the detection of antibodies to SARS-CoV-2 in human serum and plasma. It employs a recombinant nucleocapsid (N) antigen to identify adaptive immune responses, aiding in the assessment of prior infection or vaccination status. This in vitro diagnostic device is classified under serology tests for microbiological applications, specifically targeting SARS-CoV-2 serology. The assay is designed to provide results that support clinical decision-making in suspected or confirmed cases of COVID-19 exposure.
The device is supplied as a reagent kit for use on the Elecsys modular analytics platform, requiring no additional preparation beyond standard laboratory procedures. It is intended for single-use in clinical or reference laboratory settings, adhering to standard sterility and handling protocols for immunoassays. The Elecsys Anti-SARS-CoV-2 holds FDA 510(k) clearance (K250768) under the Traditional 510(k) review pathway, with classification as a Class II device (866.3983). Storage and handling follow manufacturer guidelines for immunoassay reagents, ensuring stability and performance within specified temperature ranges.
Frequently asked questions
What is the Elecsys Anti-SARS-CoV-2 used for?
The Elecsys Anti-SARS-CoV-2 is a qualitative immunoassay designed to detect antibodies against SARS-CoV-2 in human serum and plasma. It uses a recombinant nucleocapsid (N) antigen to identify adaptive immune responses, helping clinicians assess prior infection or vaccination status. This supports clinical decision-making in suspected or confirmed COVID-19 exposure cases by providing evidence of serological response.
How is the Elecsys Anti-SARS-CoV-2 supplied and prepared for use?
The device is supplied as a reagent kit specifically for use on Roche’s Elecsys modular analytics platform. No additional preparation is required beyond standard laboratory procedures. It is intended for single-use in clinical or reference laboratory settings, adhering to typical immunoassay sterility and handling protocols.
Is the Elecsys Anti-SARS-CoV-2 single-use or reusable?
The Elecsys Anti-SARS-CoV-2 is designed for single-use only. This aligns with standard practices for immunoassay reagents to ensure accuracy, sterility, and consistency in diagnostic results. Reuse is not recommended or supported by the manufacturer.
What storage conditions are required for the Elecsys Anti-SARS-CoV-2?
Storage and handling of the Elecsys Anti-SARS-CoV-2 follow manufacturer guidelines for immunoassay reagents. These guidelines specify temperature ranges to maintain stability and performance. Exact storage instructions are detailed in the accompanying documentation, but generally, reagents should be stored according to the recommended conditions to preserve their integrity and functionality.
What regulatory pathway was followed for the Elecsys Anti-SARS-CoV-2?
The Elecsys Anti-SARS-CoV-2 received FDA 510(k) clearance under the Traditional 510(k) review pathway, classified as a Class II device (product code QVP, regulation number 866.3983). This pathway confirms the device is substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use in SARS-CoV-2 antibody detection.
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: Elecsys® Anti-SARS-CoV-2 - Roche Diagnostics USA, Elecsys® Anti-SARS-CoV-2 - Roche Diagnostics USA, Revocation of Three Authorizations of Emergency Use ... - Federal Register
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250768 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K250768 24 fields · synced Oct 1, 2026