Cleared Special

K253839 - Elecsys Anti-SARS-CoV-2

K253839 is an FDA 510(k) clearance for Elecsys Anti-SARS-CoV-2, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code QVP cleared through the Special 510(k) pathway after a 16-day FDA review.

K253839 · Roche Diagnostics · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
16d
Days
Class 2
Risk

K253839 is an FDA 510(k) clearance for the Elecsys Anti-SARS-CoV-2. Classified as Sars-cov-2 Serology Test (product code QVP), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 17, 2025 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3983 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K253839

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

QVP Device Classification - Class 2, Special Controls

Product Code QVP Sars-cov-2 Serology Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QVP Sars-cov-2 Serology Test

Devices cleared under the same product code (QVP) and FDA review panel - the closest regulatory comparables to K253839.
Elecsys Anti-SARS-CoV-2 S
K252280 · Roche Diagnostics · Apr 2026
Elecsys Anti-SARS-CoV-2
K250768 · Roche Diagnostics · Jun 2025
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
DEN210038 · Ortho-Clinical Diagnostics, Inc. · May 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
DEN210040 · Ortho-Clinical Diagnostics, Inc. · May 2023
K253839 · Elecsys Anti-SARS-CoV-2
Download PDF FDA Summary Roche Diagnostics