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., Abbott Laboratories and Siemens Healthcare Diagnostics, Inc..
26
Total
26
Cleared
136d
Avg days
2006
Since
Growing category -
3 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
190d
recently vs 129d historically
FDA 510(k) Cleared Hepatitis A Test (antibody And Igm Antibody) Devices (Product Code LOL)
26 devices
Cleared
Apr 07, 2026
Elecsys Anti-HAV IgM
Roche Diagnostics
Microbiology
90d
Cleared
Jan 27, 2026
Access anti-HAV IgM
Beckman Coulter, Inc.
Microbiology
214d
Cleared
Sep 09, 2025
Access anti-HAV
Beckman Coulter, Inc.
Microbiology
267d
Cleared
Aug 10, 2023
HAVAb IgG II
Abbott Laboratories
Microbiology
323d
Cleared
Dec 09, 2022
LIAISON Anti-HAV
DiaSorin, Inc.
Microbiology
30d
Cleared
Feb 09, 2021
LIAISON Anti-HAV
DiaSorin, Inc.
Microbiology
8d
Cleared
Mar 02, 2020
LIAISON Anti-HAV Assay
DiaSorin, Inc.
Microbiology
73d
Cleared
Aug 13, 2019
Elecsys Anti-HAV II
Roche Diagnostics
Microbiology
172d
Cleared
Oct 13, 2016
ADVIA Centaur HAV IgM Assay
Siemens Healthcare Diagnostics, Inc.
Microbiology
87d
Cleared
Aug 25, 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
DiaSorin, Inc.
Microbiology
170d
Cleared
Dec 05, 2014
ADVIA Centaur HAV total assay
Siemens Healthcare Diagnostics, Inc.
Microbiology
71d
Cleared
Jul 25, 2014
LIAISON XL ANALYZER
DiaSorin, Inc.
Microbiology
86d
Cleared
Jun 28, 2012
ARCHITECT HAVAB-G
Abbott Laboratories
Microbiology
195d
Cleared
Jan 21, 2011
LIAISON XL ANALYZER MODEL 10050
DiaSorin, Inc.
Microbiology
51d
Cleared
Jun 22, 2010
ANTI-HAV IGM
Roche Diagnostics
Microbiology
181d
Cleared
Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
Bio-Rad Laboratories, Inc.
Microbiology
86d
Cleared
Oct 29, 2009
MONOLISA ANTI-HAV EIA
Bio-Rad Laboratories, Inc.
Microbiology
86d
Cleared
Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
DiaSorin, Inc.
Microbiology
140d
Cleared
Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
DiaSorin, Inc.
Microbiology
108d
Cleared
Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
Siemens Healthcare Diagnostics, Inc.
Microbiology
29d
Cleared
May 03, 2007
MONOLISA ANTI-HAV EIA
Bio-Rad Laboratories
Microbiology
182d
Cleared
May 03, 2007
MONOLISA ANTI-HAV IGM EIA
Bio-Rad Laboratories
Microbiology
182d
Cleared
Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
Abbott Laboratories
Microbiology
164d
Cleared
Sep 15, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS
Ortho-Clinical Diagnostics, Inc.
Microbiology
177d
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 510(k) Review Time - LOL Product Code
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 →