Cleared Traditional

K101946 - VIDAS TOXO IGG AVIDITY

K101946 is an FDA 510(k) clearance for VIDAS TOXO IGG AVIDITY, manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K101946 · bioMerieux, Inc. · Microbiology device
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May 2011
Decision
310d
Days
Class 2
Risk

K101946 is an FDA 510(k) clearance for the VIDAS TOXO IGG AVIDITY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 18, 2011 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 bioMerieux, Inc. devices

FDA 510(k) Submission Details - K101946

510(k) Number K101946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date May 18, 2011
Days to Decision 310 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
208d slower than avg
Panel avg: 102d · This submission: 310d
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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K101946.
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
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · DiaSorin, Inc. · Aug 2013
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · Siemens Healthcare Diagnostics, Inc. · May 2011
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