# MRR: System, Test, Low Density, Lipoprotein

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 31
- 510(k) review time 2021–2025: median 445 days (middle half 240–649)
- Recalls: 6 (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)
- 2000: 1
- 2001: 1
- 2002: 4
- 2004: 3
- 2005: 2
- 2008: 1
- 2009: 2
- 2017: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls (1999), cited by 3
- K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 (2002), cited by 3
- K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II (2004), cited by 3
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls (2008), cited by 2
- K012287: Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation (2001), cited by 2
- K982271: Wako Direct LDL-C (1998), cited by 1
- K981303: Direct LDL (1998), cited by 1
- K982529: Randox Direct LDL Cholesterol (1998), cited by 1
- K924674: Direct LDL Choles Immunoseparation Reagent (1993), cited by 1

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