Cleared Special

Elecsys Anti-SARS-CoV-2

K253839 · Roche Diagnostics · Microbiology
Dec 2025
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K253839 is an FDA 510(k) clearance for the Elecsys Anti-SARS-CoV-2, 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 review panel. Regulated under 21 CFR 866.3983.

Submission Details

510(k) Number K253839 FDA.gov
FDA Decision Cleared 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

Device Classification

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.