K253839 is an FDA 510(k) clearance for the Elecsys Anti-SARS-CoV-2. This device is classified as a Sars-cov-2 Serology Test (Class II - Special Controls, product code QVP).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 17, 2025, 16 days after receiving the submission on December 1, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3983. A Sars-cov-2 Serology Test Is A Prescription In Vitro Diagnostic Device For The Detection Of Specific Binding Antibodies To Sars-cov-2 In Clinical Specimens. The Detection Of Sars-cov-2 Antibodies Is Intended To Aid In Identifying Individuals With An Adaptive Immune Response To Sars-cov-2. The Test Is Not Intended For The Diagnosis Of Acute Sars-cov-2 Infection, Nor Screening Blood, Plasma, Cells, Or Tissue Donors..
| 510(k) Number | K253839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2025 |
| Decision Date | December 17, 2025 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QVP — Sars-cov-2 Serology Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3983 |
| Definition | A Sars-cov-2 Serology Test Is A Prescription In Vitro Diagnostic Device For The Detection Of Specific Binding Antibodies To Sars-cov-2 In Clinical Specimens. The Detection Of Sars-cov-2 Antibodies Is Intended To Aid In Identifying Individuals With An Adaptive Immune Response To Sars-cov-2. The Test Is Not Intended For The Diagnosis Of Acute Sars-cov-2 Infection, Nor Screening Blood, Plasma, Cells, Or Tissue Donors. |