Cleared Traditional

K260232 - Elecsys EBV VCA IgG

K260232 is an FDA 510(k) clearance for Elecsys EBV VCA IgG, manufactured by Roche Diagnostics. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K260232 · Roche Diagnostics · Microbiology device
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Oct 2026
Decision
249d
Days
Class 1
Risk

K260232 is an FDA 510(k) clearance for the Elecsys EBV VCA IgG. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 2, 2026 after a review of 249 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K260232

510(k) Number K260232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date October 02, 2026
Days to Decision 249 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
147d slower than avg
Panel avg: 102d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 51
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K260232.
Elecsys EBV EBNA IgG
K260221 · Roche Diagnostics · Oct 2026
ADVIA Centaur EBV-VCA IgM
K233606 · Biokit, S.A. · Aug 2024
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set
K162961 · DiaSorin, Inc. · Jan 2017
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
K162959 · DiaSorin, Inc. · Jan 2017
SERAQUEST EBV EA-D IGG TEST
K091260 · Quest Intl., Inc. · Jun 2009
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382 · Focus Diagnostics, Inc. · Jul 2008