# LOL: Hepatitis A Test (Antibody And Igm Antibody)

- Device class: 2; regulation: 21 CFR 866.3310; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 149 days (middle half 25–281)
- Recalls: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2014: 2
- 2016: 2
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- P890014: HA-Igmk and Eti-HA-Igmk (1990), cited by 3
- P890019: AB -Havk (1990), cited by 2
- P790019: Havab-M Diagnostic Kit (1980), cited by 2
- K063329: Abbott Architect Havab-M (2007), cited by 2
- P780012: HAVAB (1979), cited by 2
- K190428: Elecsys Anti-HAV II (2019), cited by 2
- K060770: Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls (2006), cited by 1
- K141116: Liaison XL Analyzer (2014), cited by 1
- K063319: Monolisa Anti-Hav Igm Eia (2007), cited by 1
- K060678: Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls (2006), cited by 1

Source page: https://510kreport.com/product-code/LOL
Data by year (CSV): https://510kreport.com/product-code/LOL.csv