Elecsys Anti-SARS-CoV-2

K253839 · Roche Diagnostics · QVP · Dec 17, 2025 · Microbiology

Device Facts

• Record ID: K253839
• Device Name: Elecsys Anti-SARS-CoV-2
• Applicant: Roche Diagnostics
• Product Code: QVP · Microbiology
• Decision Date: Dec 17, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3983
• Device Class: Class 2

Indications for Use

Elecsys Anti-SARS-CoV-2 is an immunoassay intended for the in vitro qualitative detection of total antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and Li-heparin, K2-EDTA and K3-EDTA plasma collected on or after 15 days post-symptom onset. The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e 601 immunoassay analyzer.

Device Story

Elecsys Anti-SARS-CoV-2 is an in vitro diagnostic immunoassay for the qualitative detection of antibodies to SARS-CoV-2 in human serum and plasma. The device is used in clinical laboratory settings by trained personnel. It utilizes an automated immunoassay platform to measure antibody presence, providing results that assist in identifying individuals with an adaptive immune response to SARS-CoV-2. The modification described involves updating the analytical sensitivity of the assay expressed in BAU/mL at the cut-off (1.00 COI).

Clinical Evidence

No new performance data were reviewed for this modification; substantial equivalence is based on design control activities and the determination that fundamental scientific technology remains unchanged.

Technological Characteristics

In vitro diagnostic immunoassay; automated platform; analytical sensitivity updated to BAU/mL at 1.00 COI cut-off.

Indications for Use

Indicated for individuals with suspected recent or prior SARS-CoV-2 infection, for use with human serum or plasma (Li-heparin, K2-EDTA, K3-EDTA) collected ≥15 days post-symptom onset to identify adaptive immune response.

Regulatory Classification

Identification

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay intended for the detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA). It is performed on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Predicate Devices

• Elecsys Anti-SARS-CoV-2 (K253839)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K253839

B Applicant

Roche Diagnostics

C Proprietary and Established Names

Elecsys Anti-SARS-CoV-2

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QVP | Class II | 21 CFR 866.3983 - SARS-Cov-2 Serology Test | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. This change was for updating the analytical sensitivity of the assay (in BAU/mL) at the cut-off (1.00 COI). No new performance data were reviewed.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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