Cleared Traditional

K162678 - Elecsys Toxo IgM

K162678 is an FDA 510(k) clearance for Elecsys Toxo IgM, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K162678 · Roche Diagnostics · Microbiology device
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Jun 2017
Decision
270d
Days
Class 2
Risk

K162678 is an FDA 510(k) clearance for the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 23, 2017 after a review of 270 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K162678

510(k) Number K162678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date June 23, 2017
Days to Decision 270 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
168d slower than avg
Panel avg: 102d · This submission: 270d
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 85
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K162678.
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
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