# LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 80
- Recalls: 3 (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)
- 2004: 6
- 2005: 3
- 2006: 1
- 2007: 2
- 2008: 3
- 2010: 2
- 2011: 3
- 2012: 1
- 2014: 1
- 2016: 2

## Most-cited predicates
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator (2002), cited by 7
- K982341: Direct HDL-Cholestrol Liquid (1998), cited by 3
- K963213: Boehringer Mannheim Direct HDL-Cholesterol (1996), cited by 3
- K801834: Wako HDL Cholesterol Test (1980), cited by 2
- K971526: Ace HDL-C Reagent (1997), cited by 2
- K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace (2004), cited by 2
- K972041: EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5) (1997), cited by 2
- K033610: HDL-Cholesterol Plus 2ND Generation (2003), cited by 2
- K012286: Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation (2001), cited by 1
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), cited by 1

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