Cleared Traditional

ADVIA Centaur Toxoplasma M (Toxo M)

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

About This 510(k) Submission

K142826 is an FDA 510(k) clearance for the ADVIA Centaur Toxoplasma M (Toxo M), a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on December 22, 2015, 448 days after receiving the submission on September 30, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K142826 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

Similar Devices — LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 105
Access Toxo IgG
K242022 · Beckman Coulter, Inc. · Mar 2025
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
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