FDA Product Code LGD: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Toxoplasma gondii infection poses serious risks to immunocompromised patients and fetuses. FDA product code LGD covers enzyme-linked immunosorbent assay systems for Toxoplasma gondii antibody detection.
These immunoassays detect IgG and IgM antibodies against Toxoplasma gondii in serum, enabling the diagnosis of acute and past infection. IgM detection is critical in pregnant women to identify primary infection that poses a risk of congenital toxoplasmosis.
LGD devices are Class II medical devices, regulated under 21 CFR 866.3780 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Abbott Laboratories, Beckman Coulter, Inc. and Diagnostic Products Corp..
106
Total
106
Cleared
155d
Avg days
1982
Since
Growing category -
3 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
202d
recently vs 154d historically
FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Devices (Product Code LGD)
106 devices
Cleared
Mar 28, 2025
Access Toxo IgG
Beckman Coulter, Inc.
Microbiology
260d
Cleared
Oct 11, 2024
Access Toxo IgM II
Beckman Coulter, Inc.
Microbiology
86d
Cleared
Aug 30, 2024
Alinity i Toxo IgM
Abbott Laboratories
Microbiology
260d
Cleared
May 19, 2022
ARCHITECT Toxo IgG
Abbott Laboratories
Microbiology
444d
Cleared
Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
Roche Diagnostics
Microbiology
270d
Cleared
May 18, 2011
VIDAS TOXO IGG AVIDITY
bioMerieux, Inc.
Microbiology
310d
Cleared
Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
Roche Diagnostics Corp.
Microbiology
179d
Cleared
May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
Beckman Coulter, Inc.
Microbiology
53d
Cleared
Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
Beckman Coulter, Inc.
Microbiology
24d
Cleared
Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
Beckman Coulter, Inc.
Microbiology
19d
Cleared
Sep 30, 2002
BIO-RAD PLATELIA TOXO IGM TMB
Bio-Rad
Microbiology
315d
Cleared
Sep 30, 2002
BIO-RAD PLATELIA TOXO IGG TMB
Bio-Rad
Microbiology
315d
Cleared
Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
Diagnostic Products Corp.
Microbiology
192d
Cleared
Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
Beckman Coulter, Inc.
Microbiology
238d
Cleared
Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
Beckman Coulter, Inc.
Microbiology
21d
Cleared
May 22, 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
bioMerieux, Inc.
Microbiology
231d
Cleared
Sep 17, 1998
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
Beckman Instruments, Inc.
Microbiology
371d
Cleared
Apr 24, 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
Diagnostic Products Corp.
Microbiology
269d
Cleared
Aug 23, 1996
AXSYM TOXO IGM
Abbott Laboratories
Microbiology
326d
Cleared
Aug 16, 1996
AXSYM TOXO IGG ANTIBODY ASSAY
Abbott Laboratories
Microbiology
319d
Cleared
Feb 23, 1996
IMMULITE TOXOPLASMA GONDII IGG
Diagnostic Products Corp.
Microbiology
375d
Cleared
Aug 01, 1995
IMX TOXO IGG
Abbott Laboratories
Microbiology
116d
Cleared
Apr 27, 1995
IMX(R) TOXO IGM
Abbott Laboratories
Microbiology
162d
Cleared
Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
Abbott Laboratories
Microbiology
140d
About Product Code LGD - Regulatory Context
510(k) Submission Activity
106 total 510(k) submissions under product code LGD since 1982, with 106 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LGD Product Code
Recent submissions under LGD have taken an average of 202 days to reach a decision - up from 154 days historically. Manufacturers should account for longer review timelines in current project planning.
LGD devices are reviewed by the Microbiology panel. Browse all Microbiology devices →