Cleared Special

K150375 - LIAISON VZV IgG, LIAISON Control VZV IgG

K150375 is an FDA 510(k) clearance for LIAISON VZV IgG, manufactured by DiaSorin, Inc.. The device is a Class 2 Microbiology device with product code LFY cleared through the Special 510(k) pathway after a 26-day FDA review.

K150375 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
26d
Days
Class 2
Risk

K150375 is an FDA 510(k) clearance for the LIAISON VZV IgG, LIAISON Control 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 March 11, 2015 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 - K150375

510(k) Number K150375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2015
Decision Date March 11, 2015
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

LFY Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K150375.
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · DiaSorin, Inc. · Oct 2023
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · Zeus Scientific, Inc. · Jul 2007
DIASORIN LIAISON VZV IGG
K061820 · DiaSorin, Inc. · Feb 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
K150375 · LIAISON VZV IgG, LIAISON Control VZV IgG
Download PDF FDA Summary DiaSorin, Inc.