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Elecsys Anti-SARS-CoV-2 S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252280

by Roche Diagnostics

Identifiers

510(k) Number
K252280 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 S is an electrochemiluminescence immunoassay (ECLIA) designed for the qualitative and semi-quantitative detection of antibodies against the SARS-CoV-2 spike protein receptor-binding domain (RBD) in human serum and plasma. It functions as an in vitro diagnostic test to identify individuals with an adaptive immune response to SARS-CoV-2, indicating prior or recent infection. The assay leverages immunoassay technology to measure antibody levels, aiding clinical assessment of exposure history.

This device is intended for use in laboratory settings by trained professionals, operating exclusively on cobas e immunoassay analyzers. Supplied as a single-use reagent, it requires human serum or plasma collected in lithium heparin, dipotassium-EDTA, tripotassium-EDTA, or sodium citrate. The assay is classified under FDA 510(k) clearance (K252280) as substantially equivalent to a predicate device, adhering to regulatory standards for microbiology applications. Storage and handling follow manufacturer guidelines to maintain assay integrity.

Frequently asked questions

What types of samples can the Elecsys Anti-SARS-CoV-2 S test analyze, and why is this important for clinical use?

The Elecsys Anti-SARS-CoV-2 S test is designed to analyze human serum or plasma collected in lithium heparin, dipotassium-EDTA, tripotassium-EDTA, or sodium citrate. This specificity ensures compatibility with standard laboratory workflows and reduces variability in results, as the assay relies on precise sample composition to detect antibodies against the SARS-CoV-2 spike protein. Using the wrong anticoagulant or sample type could lead to inaccurate or invalid results.

Is this device single-use, and if so, how does that impact laboratory workflows?

Yes, the Elecsys Anti-SARS-CoV-2 S is supplied as a single-use reagent, meaning each test requires a new cartridge. This design minimizes cross-contamination risk and ensures consistent performance, as reuse could compromise sterility or assay accuracy. Laboratories must account for reagent inventory management and workflow efficiency when integrating this test into their routine operations.

What analyzer platform is required to run the Elecsys Anti-SARS-CoV-2 S, and why is this important for clinicians?

The Elecsys Anti-SARS-CoV-2 S is exclusively compatible with Roche’s cobas e immunoassay analyzers. This platform-specific requirement ensures optimal assay performance, calibration, and data integration with laboratory information systems (LIS). Clinicians must confirm their lab is equipped with this analyzer to avoid operational delays or incompatibility issues.

How does the semi-quantitative nature of this test differ from a purely qualitative assay, and what clinical insights does it provide?

Unlike a purely qualitative test (which only detects presence/absence of antibodies), the Elecsys Anti-SARS-CoV-2 S provides semi-quantitative results, indicating relative antibody levels. This allows clinicians to assess not just prior infection but also the immune response magnitude, which may correlate with protection duration or severity of prior exposure. Higher antibody titers could suggest stronger immunity, though correlation with clinical protection requires further context.

What storage and handling precautions must be taken to maintain the assay’s integrity, and why are these critical?

The Elecsys Anti-SARS-CoV-2 S must be stored and handled per Roche’s guidelines to preserve its performance, though specific conditions aren’t detailed here. Critical factors typically include temperature control (e.g., refrigeration or frozen storage), protection from light, and avoiding contamination. Deviations—like improper thawing or exposure to extreme temperatures—can degrade reagents, leading to false negatives or positives, compromising diagnostic reliability.

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 S - Roche Diagnostics USA, Elecsys® Anti-SARS-CoV-2 S - Roche Diagnostics USA, PDF Elecsys Anti-SARS-CoV-2 S - assets.roche.com, Elecsys Anti-SARS-CoV-2 S - Instructions for Use

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics

Sources (1)

  • FDA 510(k) K252280 24 fields · synced Sep 20, 2026