Cleared Traditional

K231214 - LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (FDA 510(k) Clearance)

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

K231214 · DiaSorin, Inc. · Microbiology device
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Oct 2023
Decision
182d
Days
Class 2
Risk

K231214 is an FDA 510(k) clearance for the LIAISON VZV IgG HT, LIAISON Control VZV IgG HT. 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 October 27, 2023 after a review of 182 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 K231214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2023
Decision Date October 27, 2023
Days to Decision 182 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
80d slower than avg
Panel avg: 102d · This submission: 182d
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.