FDA Product Code LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Syphilis serology is a core component of STI screening. FDA product code LIP covers enzyme-linked immunosorbent assay systems for Treponema pallidum antibody detection.
These treponemal immunoassays detect IgG and IgM antibodies specific to Treponema pallidum antigens for the screening and diagnosis of syphilis. Modern EIA-based treponemal tests are increasingly used as first-line syphilis screening tests.
LIP devices are Class II medical devices, regulated under 21 CFR 866.3830 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Diagnostics, Beckman Coulter, Inc. and Ortho-Clinical Diagnostics.
FDA 510(k) Cleared Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Devices (Product Code LIP)
About Product Code LIP - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code LIP since 1982, with 35 receiving FDA clearance (average review time: 182 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LIP have taken an average of 100 days to reach a decision - down from 187 days historically, suggesting improved FDA processing for this classification.
LIP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →