Cleared Traditional

K142826 - ADVIA Centaur Toxoplasma M (Toxo M)

K142826 is the FDA 510(k) clearance for ADVIA Centaur Toxoplasma M (Toxo M) by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K142826 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Dec 2015
Decision
448d
Days
Class 2
Risk

K142826 is an FDA 510(k) clearance for the ADVIA Centaur Toxoplasma M (Toxo M). Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 448 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K142826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date December 22, 2015
Days to Decision 448 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
346d slower than avg
Panel avg: 102d · This submission: 448d
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 76
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K142826.
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
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
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc. · May 2011