FDA Product Code LOL: Hepatitis A Test (antibody And Igm Antibody)
Under FDA product code LOL, hepatitis A antibody and IgM antibody tests are cleared for the serological diagnosis of hepatitis A virus infection.
These immunoassays detect total anti-HAV antibody for immunity assessment and IgM anti-HAV for acute infection diagnosis. The presence of IgM antibody indicates recent HAV infection, distinguishing acute from past infection in patients with acute hepatitis.
LOL devices are Class II medical devices, regulated under 21 CFR 866.3310 and reviewed by the FDA Microbiology panel.
Leading manufacturers include DiaSorin, Inc., Beckman Coulter, Inc. and Abbott Laboratories.
FDA 510(k) Cleared Hepatitis A Test (antibody And Igm Antibody) Devices (Product Code LOL)
About Product Code LOL - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code LOL since 2006, with 26 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LOL have taken an average of 190 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
LOL devices are reviewed by the Microbiology panel. Browse all Microbiology devices →