LOL · Hepatitis A Test (Antibody And Igm Antibody)
Microbiology · 21 CFR 866.3310 · Class 2
Overview
| Product Code | LOL |
|---|---|
| Device Name | Hepatitis A Test (Antibody And Igm Antibody) |
| Regulation | 21 CFR 866.3310 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.
Classification Rationale
Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | Apr 7, 2026 | SESE |
| K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | Jan 27, 2026 | SESE |
| K243846 | Access anti-HAV | Beckman Coulter, Inc. | Sep 9, 2025 | SESE |
| K222850 | HAVAb IgG II | Abbott Laboratories | Aug 10, 2023 | SESE |
| K223403 | LIAISON Anti-HAV; LIAISON XS | DiaSorin, Inc. | Dec 9, 2022 | SESE |
| K210272 | LIAISON Anti-HAV | DiaSorin, Inc. | Feb 9, 2021 | SESE |
| K193532 | LIAISON Anti-HAV Assay | DiaSorin, Inc. | Mar 2, 2020 | SESE |
| K190428 | Elecsys Anti-HAV II | Roche Diagnostics | Aug 13, 2019 | SESE |
| K161964 | ADVIA Centaur HAV IgM Assay | Siemens Healthcare Diagnostics, Inc. | Oct 13, 2016 | SESE |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | DiaSorin, Inc. | Aug 25, 2016 | SESE |
| K142758 | ADVIA Centaur HAV total assay | Siemens Healthcare Diagnostics, Inc. | Dec 5, 2014 | SESE |
| K141116 | LIAISON XL ANALYZER | DiaSorin, Inc. | Jul 25, 2014 | SESE |
| K113704 | ARCHITECT HAVAB-G | Abbott Laboratories | Jun 28, 2012 | SESE |
| K103529 | LIAISON XL ANALYZER MODEL 10050 | DiaSorin, Inc. | Jan 21, 2011 | SESE |
| K100903 | ANTI-HAV | Roche Professional Diagnostics | Oct 5, 2010 | SESE |
| K093955 | ANTI-HAV IGM | Roche Diagnostics | Jun 22, 2010 | SESE |
| K092355 | MONOLISA ANTI-HAV EIA | Bio-Rad Laboratories, Inc. | Oct 29, 2009 | SESE |
| K092353 | MONOLISA ANTI-HAV IGM EIA | Bio-Rad Laboratories, Inc. | Oct 29, 2009 | SESE |
| K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | DiaSorin, Inc. | Dec 5, 2008 | SESE |
| K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | DiaSorin, Inc. | Nov 3, 2008 | SESE |
Top Applicants
- DiaSorin, Inc. — 9 clearances
- Abbott Laboratories — 5 clearances
- Siemens Healthcare Diagnostics, Inc. — 3 clearances
- Roche Diagnostics — 3 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
