Cleared Traditional

LIAISON EA IGG (K060204) - FDA 510(k) Clearance

Class I Microbiology device.

K060204 · DiaSorin, Inc. · Microbiology device
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Oct 2006
Decision
265d
Days
Class 1
Risk

K060204 is an FDA 510(k) clearance for the LIAISON EA IGG. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 18, 2006 after a review of 265 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.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K060204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2006
Decision Date October 18, 2006
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 102d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

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.