# LSR: Reagent, Borrelia Serological Reagent

- Device class: 2; regulation: 21 CFR 866.3830; FDA's rule: 510(k) required
- FDA decisions: 112
- 510(k) review time 2021–2025: median 133 days (middle half 133–197)
- Recalls: 5 (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)
- 2017: 6
- 2018: 3
- 2019: 4
- 2020: 3
- 2021: 6
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K122986: Vidas Lyme Igg (2013), cited by 3
- K950829: Mardx Lyme Disease (Igg) Marblot Strip Test System (1996), cited by 3
- K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System (1996), cited by 3
- K894224: Mardx Lyme Disease Eia (Igg) Test System (1989), cited by 3
- K220016: Viramed Borrela All-In-One ViraChip Test Kit (2022), cited by 3
- K894293: Mardx Lyme Disease Eia (Igm) Test System (1989), cited by 3
- K113846: Borrelia Burgdorferi Igm Blot Test (2012), cited by 2
- K033070: Borrelia Burgdorferi Igm Elisa Test System (2003), cited by 2
- K122979: Vidas Lyme Igm (2013), cited by 2
- K113847: Borrelia Burgdorferi Igg Blot Test (2012), cited by 2

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