Cleared Traditional

Elecsys Anti-SARS-CoV-2

K250768 · Roche Diagnostics · Microbiology
Jun 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K250768 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 (Indianpolis, US). The FDA issued a Cleared decision on June 10, 2025, 89 days after receiving the submission on March 13, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3983.

Submission Details

510(k) Number K250768 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date June 10, 2025
Days to Decision 89 days
Submission Type Traditional
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.