Cleared Traditional

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS (K052499) - FDA 510(k) Clearance

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

K052499 · Diasorin S.P.A · Microbiology device
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Feb 2006
Decision
148d
Days
Class 2
Risk

K052499 is an FDA 510(k) clearance for the DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Diasorin S.P.A (Stillwater, US). The FDA issued a Cleared decision on February 8, 2006 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - 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 S.P.A devices

Submission Details

510(k) Number K052499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date February 08, 2006
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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 - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 105
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K052499.
Access Toxo IgG
K242022 · Beckman Coulter, Inc. · Mar 2025
Access Toxo IgM II
K242095 · Beckman Coulter, Inc. · Oct 2024
Alinity i Toxo IgM
K233932 · Abbott Laboratories · Aug 2024
ARCHITECT Toxo IgG
K210596 · Abbott Laboratories · May 2022
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · Roche Diagnostics · Jun 2017
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc. · May 2011