Cleared Traditional

K052499 - DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

K052499 is an FDA 510(k) clearance for DIASORIN LIAISON TOXO IGG AND LIAISON T..., manufactured by Diasorin S.P.A. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K052499

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.

LGD Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K052499.
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · Bio-Rad Laboratories · Jul 2009
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · Roche Diagnostics Corp. · Jun 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · Beckman Coulter, Inc. · May 2008
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · Beckman Coulter, Inc. · Aug 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · Beckman Coulter, Inc. · Jun 2003
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · Bio-Rad · Sep 2002