Cleared Traditional

K233932 - Alinity i Toxo IgM

K233932 is an FDA 510(k) clearance for Alinity i Toxo IgM, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K233932 · Abbott Laboratories · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
260d
Days
Class 2
Risk

K233932 is an FDA 510(k) clearance for the Alinity i Toxo IgM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 30, 2024 after a review of 260 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K233932

510(k) Number K233932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date August 30, 2024
Days to Decision 260 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
158d slower than avg
Panel avg: 102d · This submission: 260d
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 K233932.
Access Toxo IgG
K242022 · Beckman Coulter, Inc. · Mar 2025
Access Toxo IgM II
K242095 · Beckman Coulter, Inc. · Oct 2024
ARCHITECT Toxo IgG
K210596 · Abbott Laboratories · May 2022
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