Hepatitis A Test (Antibody And Igm Antibody)
Hepatitis A Test (Antibody and IgM Antibody) is a serological diagnostic test used to detect total anti-hepatitis A virus (HAV) antibodies and/or IgM-specific antibodies in patient serum, where the presence of anti-HAV IgM indicates acute or recent infection and total anti-HAV indicates prior infection or vaccination-conferred immunity. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOL, regulated under 21 CFR 866.3310, within the Microbiology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- LOL
- Device Class
- FDA class 2
- Regulation Number
- 866.3310
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent | ABBOTT LABORATORIES |
| K223403 | LIAISON Anti-HAV; LIAISON XS | Dec 09, 2022 | Substantially Equivalent | DiaSorin Inc. |
| K210272 | LIAISON Anti-HAV | Feb 09, 2021 | Substantially Equivalent | DiaSorin Inc. |
| K193532 | LIAISON Anti-HAV Assay | Mar 02, 2020 | Substantially Equivalent | DiaSorin Inc. |
| K190428 | Elecsys Anti-HAV II | Aug 13, 2019 | Substantially Equivalent | Roche Diagnostics |
| K161964 | ADVIA Centaur HAV IgM Assay | Oct 13, 2016 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | Aug 25, 2016 | Substantially Equivalent | DiaSorin Inc. |
| K142758 | ADVIA Centaur HAV total assay | Dec 05, 2014 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K141116 | LIAISON XL ANALYZER | Jul 25, 2014 | Substantially Equivalent | DIASORIN, INC. |
| K113704 | ARCHITECT HAVAB-G | Jun 28, 2012 | Substantially Equivalent | ABBOTT LABORATORIES |
| K103529 | LIAISON XL ANALYZER MODEL 10050 | Jan 21, 2011 | Substantially Equivalent | DIASORIN, INC. |
| K100903 | ANTI-HAV | Oct 05, 2010 | Substantially Equivalent | ROCHE PROFESSIONAL DIAGNOSTICS |
| K093955 | ANTI-HAV IGM | Jun 22, 2010 | Substantially Equivalent | Roche Diagnostics |
| K092355 | MONOLISA ANTI-HAV EIA | Oct 29, 2009 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K092353 | MONOLISA ANTI-HAV IGM EIA | Oct 29, 2009 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | Dec 05, 2008 | Substantially Equivalent | DIASORIN, INC. |
| K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | Nov 03, 2008 | Substantially Equivalent | DIASORIN, INC. |
| K081716 | ADVIA CENTAUR HAVM ASSAY | Jul 17, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K063319 | MONOLISA ANTI-HAV IGM EIA | May 03, 2007 | Substantially Equivalent | Bio-Rad Laboratories |
| K063318 | MONOLISA ANTI-HAV EIA | May 03, 2007 | Substantially Equivalent | Bio-Rad Laboratories |
| K063329 | ABBOTT ARCHITECT HAVAB-M | Apr 16, 2007 | Substantially Equivalent | ABBOTT LABORATORIES |
| K060770 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS | Sep 15, 2006 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K060678 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS | Sep 14, 2006 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.