# LPS: Urinary Homocystine (Nonquantitative) Test System

- Device class: 2; regulation: 21 CFR 862.1377; FDA's rule: 510(k) required
- FDA decisions: 29
- Recalls: 11 (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)
- 1999: 4
- 2001: 5
- 2003: 2
- 2004: 1
- 2006: 6
- 2007: 2
- 2008: 2
- 2009: 1
- 2012: 4
- 2013: 1

## Most-cited predicates
- K992858: Abbott Axsym Homocysteine (1999), cited by 5
- K980907: Axis Homocysteine Enzyme Immunoassay (1998), cited by 3
- K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H (2006), cited by 3
- K993107: Bio-Rad Homocysteine by HPLC (1999), cited by 2
- K071971: Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S) Dzxxxa, Dzxxxa-Cal (2007), cited by 2
- K030754: A/C Enzymatic Homocysteine Assay (2003), cited by 1
- K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 (2009), cited by 1
- K011689: Homogeneous Enzymic Homocysteine Reagent (2001), cited by 1
- K061296: Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator (2006), cited by 1
- K003597: Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2 (2001), cited by 1

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