# LBR: Ldl & Vldl Precipitation, Hdl

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 66
- Recalls: 9 (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)
- 1995: 2
- 1996: 1
- 1997: 3
- 1998: 3
- 1999: 5
- 2001: 1
- 2002: 1
- 2005: 1
- 2008: 1
- 2015: 1

## Most-cited predicates
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set (1997), cited by 7
- K974733: Boehringer Mannheim Direct LDL - Cholesterol (1998), cited by 3
- K990247: MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470 (1999), cited by 2
- K962186: N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator (1996), cited by 2
- K012593: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2 (2001), cited by 1
- K830207: Raichem HDL-Cholesterol Reagent (1983), cited by 1
- K984303: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent (1999), cited by 1
- K050823: Direct HDL Cholesterol and Direct HDL/LDL Calibrator (2005), cited by 1

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