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 and Beckman Coulter, Inc..
FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Devices (Product Code LGD)
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 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
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 →