Cleared Traditional

K250768 - Elecsys Anti-SARS-CoV-2 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250768 · Roche Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
89d
Days
Class 2
Risk

K250768 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 June 10, 2025 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K250768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K250768.
Elecsys Anti-SARS-CoV-2 S
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DEN210038 · Ortho-Clinical Diagnostics, Inc. · May 2023
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DEN210040 · Ortho-Clinical Diagnostics, Inc. · May 2023