# DFC: Lipoprotein, Low-Density, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5600; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 445 days (middle half 357–534)
- 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)
- 2001: 2
- 2002: 4
- 2005: 1
- 2007: 1
- 2009: 1
- 2012: 2
- 2018: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K082488: Diazyme LP (a) Assay (2009), cited by 2
- K180074: Diazyme Lipoprotein (a) Assay (2018), cited by 2
- K000121: Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a) Lpa Reagent, Lipoprotein (a) Calib (2000), cited by 2
- K013128: N Latex LP (a) (2002), cited by 2
- K013359: LP (a)-Latex Seiken Assay Kit (2002), cited by 2
- K980812: Imx Homocysteine (1998), cited by 1
- K992665: Macra LP (a) Enzyme Immunoassay Kit (1999), cited by 1
- K050487: Quantia LA (a) (2005), cited by 1
- K990595: Integra Reagent Cassette for Apolipoprotein B (1999), cited by 1
- K982708: SPQ Test System (1999), cited by 1

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