Cleared Traditional

K131441 - LIAISON TOXO IGM II

K131441 is the FDA 510(k) clearance for LIAISON TOXO IGM II by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K131441 · DiaSorin, Inc. · Microbiology device
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Aug 2013
Decision
81d
Days
Class 2
Risk

K131441 is an FDA 510(k) clearance for the LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K131441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date August 09, 2013
Days to Decision 81 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
21d faster than avg
Panel avg: 102d · This submission: 81d
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 57
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K131441.
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · Roche Diagnostics · Jun 2017
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · Siemens Healthcare Diagnostics, Inc. · Dec 2015
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
K132234 · DiaSorin, Inc. · Aug 2013
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc. · May 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · Siemens Healthcare Diagnostics, Inc. · May 2011
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · Roche Diagnostics Corp. · Jun 2008