Cleared Traditional

K061820 - DIASORIN LIAISON VZV IGG

K061820 is the FDA 510(k) clearance for DIASORIN LIAISON VZV IGG by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LFY) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K061820 · DiaSorin, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
243d
Days
Class 2
Risk

K061820 is an FDA 510(k) clearance for the DIASORIN LIAISON VZV IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on February 26, 2007 after a review of 243 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 K061820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2006
Decision Date February 26, 2007
Days to Decision 243 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
141d slower than avg
Panel avg: 102d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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 - LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

All 10
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K061820.
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
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LIAISON VZV IgG, LIAISON Control VZV IgG
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ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · Zeus Scientific, Inc. · Jul 2007
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · Zeus Scientific, Inc. · Dec 2005
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181 · Zeus Scientific, Inc. · Jan 1999
IS-VZU IGG TEST SYSTEM
K981867 · Diamedix Corp. · Sep 1998